Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case! Your contact information is not shown on the website.
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Use camera
Select from library
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!
IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)
Visit our learn pages for more helpful information or, email us: support@safelyhq.com
Goodbye! and best wishes in your recovery
Report by
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

If your report is poison related call 1-800-222-1222 for a free consultation with a live medical poisoning expert

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Daptomycin for Injection - recalled due to Presence of particulate matter, USA

July 7, 2020 3:00 PM

United States

Daptomycin for Injection - recalled due to Presence of particulate matter, USA

Company name: Mylan Institutional LLC
Brand name: Mylan
Product recalled: Daptomycin for Injection
Reason of the recall: Presence of particulate matter
FDA Recall date: July 07, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.

Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:

- NDC #: 67457-813-50
- Material Description: Daptomycin for Injection
- Strength: 500 mg/vial
- Size: 20 mL vial
- Lot No: 7605112
- Expiry: October 2021

Daptomycin for injection is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop use/further distribution or dispensing.

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

Reported By SafelyHQ.com User
More incidents from:
Drugs
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
See Less
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

Insects in Food, Italist Pizza Pasta Bar, проспект Соборності, Kyiv, Ukraine

Italist Pizza Pasta Bar, проспект Соборності, Kyiv, Ukraine

September 5, 2020 12:03 PM

“Midgets in restaurant flying over my food, disgusting, waiter said it’s “nature” See Less
Reported By SafelyHQ.com User

September 20, 2020 9:38 PM

“The CFIA announced the recall of PC Blue Menu brand Artichoke & Asiago Dip by Loblaw Companies Limited from the marketplace due it may contain egg which is not declared on the label. There have been no reported illnesses associated with the consumption of this product.

CFIA advises consumers not... See Moreto eat the recalled products and return them to the place of purchase for a full refund. The products were distributed nationwide.

- PC Blue Menu Artichoke & Asiago Dip (on lid) (side label states Tzatziki Yogurt Dip). Size: 227 g. UPC: 0 60383 03697 3. Codes: 2020 OC 31.

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

Source: CFIA
See Less
Reported By SafelyHQ.com User

August 25, 2020 8:00 AM

“Company name: Sunshine Mills, Inc.
Brand name: Nature’s Menu
Product recalled: Nature’s Menu Super Premium Dog Food with a Blend of Real Chicken & Quail
Reason of the recall: Salmonella
FDA Recall date: August 24, 2020
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall of Nature... See More’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail because of the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled products were distributed in retail stores nationally and can be identified with the following UPC 7015514363 and UPC 7015514365.

- The product comes in a 3-pound bag with the following lot codes:
TE1 20/April /2020, TE1 21/April/2020, TE1 22/April/2020, TE2 20/April /2020, TE2 21/April/2020, TE2 22/April/2020, TE3 20/April/2020, TE3 21/April/2020, TE3 22/April/2020.

- The product comes in a 13.5-pound bag with the following lot codes:
TB1 20/April /2020, TB1 21/April/2020, TB1 22/April/2020, TB2 20/April /2020, TB2 21/April/2020, TB2 22/April/2020, TB3 20/April/2020, TB3 21/April/2020, TB3 22/April/2020.

No illnesses, injuries or complaints have been reported to date. There are no other Nature’s Menu® products or other lot codes of the Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail affected by this precautionary recall. The potential for contamination was noted after the firm was notified by the Georgia Department of Agriculture when a sample of a single 3-pound bag of the product was collected and tested positive for Salmonella. 

The firm conducted testing of multiple samples of the same lot which all tested negative for Salmonella. Salmonella may not be evenly distributed throughout a lot which is why it could have been found on one sample and not on multiple other samples of the same lot.  However, out of an abundance of caution, Sunshine Mills, Inc. has chosen to issue a voluntary recall of the above-referenced lots of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail in furtherance of its commitment to the safety and quality of its products. Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves. 

Consumers who have purchased Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail from the recalled lots should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers may contact Sunshine Mills, Inc. customer service at (800) 705-2111 from 7AM to 4PM Central Time, Monday through Friday, or by email at customer.service@sunshinemills.com for additional information.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

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
See Less
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
See Less
Reported By SafelyHQ.com User

September 21, 2020 5:00 PM

“Company name: GHSW, LLC
Brand name: Trader Joe’s
Product recalled: Southwest Style Sweet Potato Saute Bowl
Reason of the recall: Undeclared milk and egg
FDA Recall date: September 21, 2020
Recall details: GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Pot... See Moreato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label.  People who are allergic to milk and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

The dressing is located in a pouch found inside the clear 21.5 oz. bowl. These bowls are sold in the refrigerated section of the store. The recalled product(s) were shipped to 36 Trader Joe’s stores in the following states:  AR, CO, KS, LA, NM, OK, TN, and TX. The recall has been isolated to only Southwest Style Sweet Potato Sauté Bowl with the Best By dates 09/23/20, 09/24/20, 09/25/20, 09/26/20, and 09/28/20 on the front of the package.

No other products or lots are affected by this recall. No reports of illnesses or injury have been received to date. The recall was initiated after it was discovered that the dressing containing milk and egg was distributed in packaging that did not declare the presence of milk or egg. GHSW, LLC is urging customers with any milk and egg allergy concerns to return the product to the point of purchase for a full refund or dispose of the recalled products.  GHSW is standing by to answer customer questions at 888-449-9386, M-F, 9 am to 4 pm PST.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.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 SafelyHQ.com User

September 14, 2020 10:41 AM

“I was do discussed I took one bite of my cheeseburger There was a long black curly hair wrapped into all around the burger it wasn't just a little piece of hair it was long and curly very bad turned me off from eating there now and I ate there lots it was on 09/05/2020 @ 2:46pm I took it back to the... See Morem rite away. I haven't posted the picture .. yet but feel like I should People shouldn't have to check and look at ther food especially from a place like this should n able to trust that ther nothing in there that shouldn't b why are they not wearing hair nets!? I watched the girls making the food in the back no one is wearing hair nets See Less
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
See Less
Reported By SafelyHQ.com User

September 10, 2020 9:00 PM

“Company name: Pretty Thai
Brand name: Pretty Thai
Product recalled: Pretty Thai Sweat Chili Sauce
Reason of the recall: May contain Pretty Thai Peanut Sauce
FDA Recall date: September 10, 2020
Recall details: Company Announcement Pretty Thai of Austin, Texas, is recalling Pretty Thai Peanut Sau... See Morece that may have been mislabeled as Pretty Thai Sweet Chili Sauce. There is a risk that a person with an allergy or severe sensitivity to peanuts could unintentionally consume a product containing peanuts because of this error. No illnesses have been reported to date.

The product was distributed to H-E-B and Central Market stores in Texas from March 19, 2020 to September 8, 2020. The product is packaged in clear, cylindrical PET bottles with black flip-top caps and clear labels with white print. The recall is for Pretty Thai Peanut Sauce with the Lot Code 0772000123. A small number of the Pretty Thai Peanut Sauce bottles were discovered to have been mislabeled as Pretty Thai Sweet Chili Sauce. Pretty Thai Peanut Sauce is yellow or gold in color, while Pretty Thai Sweet Chili Sauce is dark red in color. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume the mislabeled product.

Pretty Thai and its manufacturer, Ponder Foods, have coordinated efforts with H-E-B to remove all of the affected product from the shelves and from distribution. Out of an abundance of caution, we are alerting consumers in Texas who may have purchased either Pretty Thai Peanut Sauce or Pretty Thai Sweet Chili Sauce to check any product for Lot Code 0772000123. For consumers with no peanut allergy, this Lot Code of Pretty Thai Peanut Sauce, as well as any Lot Code of Pretty Thai Sweet Chili Sauce are completely safe to consume. Product may be returned to H-E-B and/or Central Market for a full refund. Subsequent investigation indicates the problem was caused by a temporary breakdown in the manufacturer's production and packaging processes.

Consumers with questions may contact the Pretty Thai brand directly via email at info@ptfawg.com or via telephone at 512 981 6170. Consumers or retailers may also contact the manufacturer, Ponder Foods, via email at info@ponder-foods.com or via telephone at 469 914 0052 (M-F, 9:00am-5:00pm CDT). Attached below is a photo of the mislabeled product with the affected Lot Code.  

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User