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Bersih Hand Sanitizer Gel - recalled due to Potential Methanol Contamination, USA

July 14, 2020 8:01 PM

United States

Bersih Hand Sanitizer Gel - recalled due to Potential Methanol Contamination, USA

Company name: Soluciones Cosmeticas
Brand name: Bersih
Product recalled: Hand Sanitizer Gel
Reason of the recall: Potential Methanol Contamination
FDA Recall date: July 14, 2020
Recall details: Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). To date Soluciones Cosméticas has not received reports of adverse events related to this recall.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

The product is used as a hand sanitizer and is packaged in 16.9 ounce plastic clear bottles with blue tops with UPC Code 816822026667. The lot numbers range from 0106K01 to 0148K01. This product was distributed nationwide to wholesale distributors and retailers.

Soluciones Cosméticas is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase. Consumers with questions regarding this recall can contact Soluciones Cosméticas at 866-912-8410 Monday through Friday 8am to 5pm Eastern Time or by email at bersihrecall6551@stericycle.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Drugs
Hand Sanitizer
United States

Related Reports

September 17, 2020 11:00 PM

“Company name: Acella Pharmaceuticals, LLC
Brand name: NP Thyroid 15 & NP Thyroid120
Product recalled: Thyroid Tablets
Reason of the recall: Sub Potency
FDA Recall date: September 17, 2020
Recall details: Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg... See MoreNP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images. To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Additionally, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020.

Product NDC Lot # Exp. Date
NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg) 42192-327-01 M327E19-1 October 2020
NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01 M328F19-3 November 2020

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

September 10, 2020 5:00 PM

“Company name: Medek, LLC
Brand name: M
Product recalled: M Hand Sanitizer Alcohol Antiseptic 80%
Reason of the recall: Contains Methanol and may be Sub-Potent for Ethanol
FDA Recall date: September 10, 2020
Recall details: Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcoh... See Moreol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. In addition, the use of sub-potent hand sanitizer products can have adverse health consequences related to lack of efficacy and increased risk of infections. To date, Medek, LLC. has not received any reports of adverse.

The recalled product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The recalled Hand Sanitizer is packaged in a one (1) gallon (128 oz/3,785 mL) High-density polyethylene (HDPE) plastic bottle, NDC 75432-001-02. The recalled Hand Sanitizer was distributed directly to walk-in customers in Alamo, TX, between the dates of 04/17/2020 to 05/22/2020.

Medek, LLC is notifying its customers/distributors by recall letter and consumers via this press release. We are also notifying our distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled Hand Sanitizer. Consumers, distributors, and retailers that have recalled products should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Medek, LLC at (956) 800-4366 (Monday to Friday from 9 am to 5 pm CST).

Consumers should contact their physician or healthcare provider if they experience any problem that may be related to the use of this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

September 5, 2020 12:01 PM

“Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within e... See Morexpiry to the consumer level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.  The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles. 

Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

September 4, 2020 7:00 AM

“Company name: RLC Labs, Inc
Brand name: RLC Labs
Product recalled: Nature-Throid® and WP Thyroid®
Reason of the recall: Product may be sub potent
FDA Recall date: September 02, 2020
Recall details: RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in... See Moreall strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

RLC Labs, Inc. has not received any reports of adverse events related to this recall. Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles. To best identify the product, the NDC’s, Product Descriptions, Lot Numbers and Expiration Dates are listed in the link below.

These lots were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies. RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

September 3, 2020 7:00 PM

“Company name: AJR Trading LLC
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Possible presence of methanol
FDA Recall date: September 03, 2020
Recall details: AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currentl... See Morey in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests. However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085.  AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020. AJR Trading is notifying its customers by phone calls, e-mails, and letters.  AJR Trading is arranging for refund and destruction of recalled products.

Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the following address for refund: 814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134. Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to ajrtrading15@gmaill.com Monday to Friday from 10:00 am to 5:00 pm Central Time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

September 1, 2020 6:14 PM

“Company name: The Protein Shoppe, LLC
Brand name: Red-E
Product recalled: Red-E male enhancement tablet
Reason of the recall: Product contains undeclared sildenafil
FDA Recall date: September 01, 2020
Recall details: Company Announcement The Protein Shoppe, LLC is voluntarily recalling all lots... See Moreof “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction.

The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that is life threatening and could result in serious adverse health consequences. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date The Protein Shoppe, LLC has not received any reports of adverse events related to this recall. The product, Red-E (Male Enhancement tablet), is marketed as a male enhancement nutritional supplement, the product is a scored octagonal tablet with “Red” embossed on either side of the score line on one side of the tablet which is contained in small plastic bag with a black label stapled to it, UPC. The Red-E pill was sold online at the website: www.rgvproteinshoppe.com.

The Protein Shoppe, LLC is notifying its customers with this press release and is arranging for return of all recalled products. Consumers that have The Red-E pill (male enhancement tablet), which is being recalled, should stop using and return to place of purchase. Consumers with questions regarding this recall can contact The Protein Shoppe by phone at 956-687-3539, Monday through Friday from 10 AM to 6 PM CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

August 31, 2020 4:00 PM

“Company name: Mylan N.V.
Brand name: Mylan
Product recalled: Tranexamic Acid and Amiodarone HCl injections
Reason of the recall: Vials potentially packaged in incorrect cartons
FDA Recall date: August 31, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan In... See Morestitutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.

These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.

Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.

If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events. Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:

NDC #: 67457-153-09
Material Description: Amiodarone HCl Injection, USP
Strength: 450 mg/9 mL
Carton Size: 10 x 9 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

NDC #: 67457-197-10
Material Description: Tranexamic Acid Injection, USP
Strength: 1000 mg/10 mL
Carton Size: 10 x 10 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing.

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

August 28, 2020 3:00 PM

“Company name: HARMONIC NATURE S. DE R.L. Mi
Brand name: Harmonic Nature
Product recalled: Hand sanitizer
Reason of the recall: Product contains 1 propanol
FDA Recall date: August 28, 2020
Recall details: Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Saniti... See Morezer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol.

Risk Statement: Any amount of 1-propanol with a concentration greater than or equal to 1% by volume that is unlisted in a product labeled as an ethanol-based hand sanitizer has a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product.

Harmonic Nature has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer and is packaged in 250 mL plastic bottles , with UPC Code 7500462892210. The product can be identified by Harmonic Nature as a hand sanitizer Topical Solution distributed only to and currently on hold at the US custom bróker, Aquiles INC. Harmonic Nature is notifying Aquiles INC. and is arranging for return of all recalled product. Consumers with questions regarding this recall can contact Harmonic Nature by +(52) 8120 2967 03 or miguel_martinez2000@yahoo.com Monday to Friday from 8:00 am to 6:00pm central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. CDER’s press statement

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

August 26, 2020 4:00 PM

“Company name: Nanomateriales, SA de CV
Brand name: Zanilast+
Product recalled: Hand sanitizer
Reason of the recall: Product contains 1-propanol.
FDA Recall date: August 26, 2020
Recall details: Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel... See More, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol.

Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product.

Nanomateriales, SA de CV has not received any reports of adverse events related to this recall. The product is used as a sanitizer gel, for hand washing to decrease bacteria on the skin and is packaged in 1 liter, 25 liters, and 1 gallon plastic bottles distributed from 05/29/2020 to 06/17/2020 in the States of California, New York and New Jersey.

Presentatio UPC NDC Lable
1 Liter 2 000000 531151 69912-008-01 See below
25 Liter 2 000000 531151 69912-006-01 See below
1 galon 2 000000 531144 69912-008-02 See below

Nanomateriales, SA de CV is notifying its distributors and customers by e-mail and phone and is arranging for return of all recalled products. Consumers and distributors that have ZANILAST+ GEL which is being recalled should return to place of purchase.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

August 25, 2020 7:00 PM

“Company name: Asiaticon SA de CV
Brand name: V-Klean, Medical Minded, Protz
Product recalled: Hand Sanitizer
Reason of the recall: Potential presence of methanol (wood alcohol) and subpotent ethanol levels
FDA Recall date: August 25, 2020
Recall details: Mexico City, Mexico, Asiaticon SA de CV... See More(Mexico) is voluntarily recalling all lots of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer sold in 13.5, 16.9 and 33.8 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) and subpotent ethanol levels.

Risk Statement:  Methanol has inferior antiseptic properties compared to ethanol.  Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.  Although all person using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date Asiaticon SA de CV has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and is packaged in plastic clear bottles with clear tops with UPC Code:

- V-Klean in 8.5 fl. oz. (250 ml) bottles: 716053704993
- V-Klean in 16.9 fl. oz. (500 ml) bottles: 716053704993
- V-Klean in 33.8 fl. oz. (1000 ml) bottles: 716053704993
- Medically Minded in 16.9 fl. oz. (500 ml) bottles: 676753003782
- Protz in 13.5 fl. oz. (400 ml) bottles: 7503019005002

The recall includes all lots.  This product was exported to different distributors nationwide. Asiaticon SA de CV is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Asiaticon SA de CV per the below for disposal instructions or return it to the place of purchase. Consumers with questions regarding this recall can contact Asiaticon SA de CV at direccion@asiatic-connection.com (0052 1 55 21553488). 

In the US: at 929 394 3020 (available Monday to Friday 9.30 am  6 pm eastern time) Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By Iwaspoisoned.com User

Recent Interesting Reports

September 4, 2020 7:00 AM

“Company name: RLC Labs, Inc
Brand name: RLC Labs
Product recalled: Nature-Throid® and WP Thyroid®
Reason of the recall: Product may be sub potent
FDA Recall date: September 02, 2020
Recall details: RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in... See Moreall strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

RLC Labs, Inc. has not received any reports of adverse events related to this recall. Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles. To best identify the product, the NDC’s, Product Descriptions, Lot Numbers and Expiration Dates are listed in the link below.

These lots were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies. RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 5, 2020 12:01 PM

“Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within e... See Morexpiry to the consumer level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.  The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles. 

Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 4:36 PM

“Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of Ancient Grain Jackfruit Bowl sold at Publix because it may contain an undeclared allergen, FISH (anchovies). People who have an allergy or severe sensitivity to FISH (anchovies) run the risk of serious or life-threatening allergic... See Morereaction if they consume these products.

The allergy alert was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing Fish was distributed in packaging that did not reveal the presence of fish. Subsequent investigation indicates the problem was caused by sourcing the wrong sub-ingredient.

- Eat Fresco Ancient Grain Jackfruit Bowl. GTIN: 85898800510. Lot/Exp. Date: ALL

Individuals with an allergy or sensitivity to fish (anchovies) should not consume this product. Households that include individuals with an allergy or sensitivity to fish (anchovies) should dispose of the product or return it to the place of purchase for a refund.

Consumers with questions may contact Fresco Foods, Inc. at (813) 551-2100.

Check the full recall details on corporate.publix.com

Source: Publix
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Reported By SafelyHQ.com User

September 3, 2020 7:00 PM

“Company name: AJR Trading LLC
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Possible presence of methanol
FDA Recall date: September 03, 2020
Recall details: AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currentl... See Morey in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests. However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085.  AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020. AJR Trading is notifying its customers by phone calls, e-mails, and letters.  AJR Trading is arranging for refund and destruction of recalled products.

Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the following address for refund: 814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134. Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to ajrtrading15@gmaill.com Monday to Friday from 10:00 am to 5:00 pm Central Time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 16, 2020 9:38 PM

“The FSIS announced the recall of approximately 6,890 pounds of ready-to-eat (RTE) chicken salad products by Willow Tree Poultry Farm, Inc due to misbranding and an undeclared allergen. The products may contain walnuts, a known allergen, which are not declared on the product labels. There have been n... See Moreo confirmed reports of adverse reactions due to consumption of these products to date.

FSIS advises consumers not to eat the recalled products and to throw them away or return them to the place of purchase. The RTE chicken salad product labeled as “Classic Chicken Salad” may actually contain “White Meat Cranberry Walnut Chicken Salad” and was produced on Sept. 2, 2020. The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items were shipped to retail locations in Connecticut, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, Rhode Island, Vermont and Virginia. The following products are subject to recall:

- 15-oz. clear, plastic containers labeled as “Willow Tree Premium White Meat CHICKEN SALAD Classic” with a sell by date of “9/30/20” and a time stamp of 13:00:00 through 17:00:00 on the containers’ cellophane lid.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS
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Reported By SafelyHQ.com User

My entire body was covered in hives!!!, Halal Food Truck, Charlotte, NC, USA

Symptoms: Skin Rash
Halal Food Truck, Charlotte, NC, USA

August 22, 2020 10:30 PM

“My roommate and i went to get a quick bite to eat from there. Went home and ate and about 30-45 mins afterwards i noticed what felt like multiple mosquito bites itching in multiple areas of my body..no worries i thought that mosquito must've gotten me pretty good! Wasnt til about 4 or 5 am i got up... See Moreto use the restroom and still itching but severly this time..to my surprise when i walked into the bathroom and cut on the lights i could clearly see these arent mosquito bites!! My entire body was covered in hives!!! Im pretty sure its an allergic reaction to the special "red sauce" they use in their food.. Anyone know what that sauce is? Steer clear when ordering!! Ive broken out twice in 24hrs!!!! See Less
Reported By SafelyHQ.com User

September 7, 2020 8:36 PM

“The CFIA announced the recall of Frank brand Milk Chocolate Covered Raisins by Canadian Tire Corporation of Canada from the marketplace due to undeclared peanut.

- Frank Milk Chocolate Covered Raisins (300 g). UPC: 6 26394 33920 7. Best Before 2021 MA 07, Lot: 07EUA | Best Before 2021 MA 13, Lot... See More: 13EUA | Best Before 2021 JL 07, Lot: 07GUB | Best Before 2021 APR 21, Lot: 21DUB | Best Before 2021 JL 08, Lot: 08GUB

Check the full recall details on the CFIA website: inspection.gc.ca

Source: CFIA
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Reported By SafelyHQ.com User

September 17, 2020 11:00 PM

“Company name: Acella Pharmaceuticals, LLC
Brand name: NP Thyroid 15 & NP Thyroid120
Product recalled: Thyroid Tablets
Reason of the recall: Sub Potency
FDA Recall date: September 17, 2020
Recall details: Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg... See MoreNP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images. To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Additionally, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020.

Product NDC Lot # Exp. Date
NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg) 42192-327-01 M327E19-1 October 2020
NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01 M328F19-3 November 2020

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 2, 2020 11:41 PM

“The FSA announced the recall of Lamb and Carrot Dumplings by Freshasia Foods because they contain crustaceans, which are not mentioned on the label. This means the product is a possible health risk for anyone with an allergy to crustaceans.

FSA advises consumers not to eat the recalled product. I... See Morenstead, return it to the store from where it was bought for a full refund.

+ Freshasia Lamb and Carrot Dumplings. 400g. Batch code: 200402. Best before: 6 April 2021

Freshasia Foods is recalling the above product from customers and has been advised to contact the relevant allergy support organisations, which will tell their members about the recall. The company has also issued a point-of-sale notice to its customers. These notices explain to customers why the product is being recalled and tell them what to do if they have bought the product.

Check the full recall details on food.gov.uk

Source: FSA
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Reported By SafelyHQ.com User

September 1, 2020 6:14 PM

“Company name: The Protein Shoppe, LLC
Brand name: Red-E
Product recalled: Red-E male enhancement tablet
Reason of the recall: Product contains undeclared sildenafil
FDA Recall date: September 01, 2020
Recall details: Company Announcement The Protein Shoppe, LLC is voluntarily recalling all lots... See Moreof “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction.

The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that is life threatening and could result in serious adverse health consequences. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date The Protein Shoppe, LLC has not received any reports of adverse events related to this recall. The product, Red-E (Male Enhancement tablet), is marketed as a male enhancement nutritional supplement, the product is a scored octagonal tablet with “Red” embossed on either side of the score line on one side of the tablet which is contained in small plastic bag with a black label stapled to it, UPC. The Red-E pill was sold online at the website: www.rgvproteinshoppe.com.

The Protein Shoppe, LLC is notifying its customers with this press release and is arranging for return of all recalled products. Consumers that have The Red-E pill (male enhancement tablet), which is being recalled, should stop using and return to place of purchase. Consumers with questions regarding this recall can contact The Protein Shoppe by phone at 956-687-3539, Monday through Friday from 10 AM to 6 PM CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User