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Curfew Announcement in your area until further notice, Orange County, Florida, USA

June 2, 2020 12:00 PM

Florida, United States

Curfew Announcement in your area until further notice, Orange County, Florida, USA

Mayor Jerry Demings (D) signed an emergency executive order on May 31 that imposed a curfew from 10 p.m. to 5 a.m. It will remain in effect until terminated by executive order. Source: thehill.com

Reported By SafelyHQ.com User
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“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

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

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 SafelyHQ.com User