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FDA MedWatch Alerts

Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient

December 14, 2017

Audience: Consumer. [Posted 12/14/2017] ISSUE: Marmex Corp is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil. The presence of the undeclared active ingredients renders them unapproved drugs for which safety and efficacy have not been established. Use of products with undeclared sildenafil...

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Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

December 5, 2017

Audience: Pharmacy, Consumer. [Posted 12/05/2017] ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are: SD2070421201 (Exp. 12/2019) SD2070420925 (Exp....

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Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

December 1, 2017

Audience: Risk Manager, Critical Care Medicine, Emergency Medicine. ISSUE: During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes. CSL Behring is taking no action with products on the market but is addressing the print settings to...

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Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients

December 1, 2017

Audience: Consumer. [Posted 12/01/2017] ISSUE: Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan...

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Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests

November 28, 2017

Audience: Laboratory, Health Professional, Patient. ISSUE: The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically...

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Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination

November 27, 2017

Audience: Pharmacy, Patient. ISSUE: Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract,...

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Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

November 21, 2017

Audience: Consumer, Health Professional. ISSUE: The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them:...

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Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets

November 17, 2017

Audience: Pharmacy, Risk Manager, Patient. ISSUE: Greenstone, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Products were distributed nationwide to wholesalers/retailers from...

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Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

November 15, 2017

Audience: Pharmacy, Cardiology, Risk Manager. ISSUE: Baxter International announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. The particulate matter may have entered the solution during t...

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Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

November 15, 2017

Audience: Rheumatology, Internal Medicine, Patient. ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final...

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Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use

November 14, 2017

Audience: Patient, Plastic Surgery, Dermatology, Surgery. [Posted 11/14/2017] ISSUE: The FDA is alerting the public and health care providers that injectable silicone is not approved to enhance or augment the body. Such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death. The FDA is aware of cases...

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Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events

November 8, 2017

Audience: Health Professionals. ISSUE: FDA received an adverse event report stating that two patients developed what is described in the report as tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, LLC, located in West Palm Beach, Florida. According to the report, a sample of the product was sent...

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Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility

November 6, 2017

Audience: Consumer, Pharmacy. Including: Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine [Posted 11/06/2017] ISSUE: Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra...

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Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi: Recall - Reports of Blister Packages Containing Syringes of Ondansetron Injection

November 3, 2017

Audience: Pharmacy, Surgery, Risk Manager. ISSUE: Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL. The affected Lot is 6400048.. BACKGROUND: A missed...

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Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal

October 23, 2017

Audience: Pharmacy, Risk Manager. ISSUE: Octapharma USA Inc. is initiating a voluntary market withdrawal of Octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through consultation with the public health authorities at FDA, the most prudent ...

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Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

October 21, 2017

Audience: Pharmacy, Health Professional. ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination.  See the recall notice for a full list of products. BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination ha...

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A1 Slim by Kiriko : Recall - Undeclared Drug Ingredients

October 7, 2017

Audience: Consumer. ISSUE: Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level.  FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established; therefore, subject to ...

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Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

October 6, 2017

Audience: Risk Manager, Pharmacy. ISSUE: Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing...

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Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

October 3, 2017

Audience: Opthalmology, Pharmacy. ISSUE: FDA received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV) after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgery procedures that were...

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Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient

September 21, 2017

Audience: Consumer. [Posted 09/21/2017] ISSUE: Natures Supplement, Inc. is voluntarily recalling 260 bottles of Vegetable Vigra, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction. The presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and...

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FDA MedWatch Alerts Archive