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FDA MedWatch Alerts

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Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

August 18, 2017

Audience: Health Care Professionals. [Posted 08/18/2017] ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date,...

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Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

August 16, 2017

Audience: Pharmacy, Psychiatry, Patient. ISSUE: Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse...

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Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

August 10, 2017

Audience: Pharmacy, Patient. ISSUE: International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A This lot of...

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Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination

August 10, 2017

Audience: Pharmacy, Patient. [Posted 08/10/2017] ISSUE: The distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination. Through recent communication with FDA, the distribution firm Rugby...

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Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance

August 10, 2017

Audience: Pharmacy, Health Professional, Patient. ISSUE: FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary c...

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Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

August 8, 2017

Audience: Pharmacy, Patient, Health Professional. ISSUE: FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products – Diocto Liquid and Diocto S...

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Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

August 4, 2017

Audience: Consumers, Health Care Professionals. ISSUE: The U.S. Food and Drug Administration is warning parents and caregivers not to use “Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine” due to the risk of lead poisoning. FDA has not reviewed this product for safety or effectiveness. Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system. In children, chr...

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Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Use

August 4, 2017

Audience: Health Professional, Pharmacy. [Posted 08/04/2017] ISSUE: Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with  polyethylene glycol (PEG) 40 castor oil reportedly experienced immediate hypersensitivity reactions.  The PEG 40 castor oil was a component of a curcumin emulsion product compounded by a pharmacy, ImprimisRx, located in Irvine, California. H...

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Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination

August 3, 2017

Audience: Pharmacy, Patient, Consumer. [Posted 08/03/2017] ISSUE: Rugby Laboratories is voluntarily recalling all lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia. FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients which may be linked to Diocto...

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Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient

July 31, 2017

Audience: Consumer. [Posted 07/31/2017] ISSUE: Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil. The product has/potentially could result in death. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. BACKGROUND: The product is marketed as...

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0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter

July 31, 2017

Audience: Pharmacy. [Posted 07/31/2017] ISSUE: ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local...

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Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

July 28, 2017

Audience: Ophthalmology, Pharmacy, Patient. [Posted 07/28/2017] ISSUE: FDA received adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered Guardian’s product at the e...

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Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling

July 28, 2017

Audience: Pharmacy, Health Professional. ISSUE: Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing...

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Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

July 25, 2017

Audience: Health Professional, Risk Manager. [Posted 07/25/2017] ISSUE: Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. Administration of a drug product ...

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La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient

July 25, 2017

Audience: Consumer. [Posted 07/25/2017] ISSUE: EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an...

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Super Panther 7K by Ultra Shop Supplement: Recall - Undeclared Drug Ingredients

July 24, 2017

Audience: Consumer. [Posted 07/24/2017] ISSUE: Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, (1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry), distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved...

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Sten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic Steroids

July 12, 2017

Audience: Consumer. ISSUE: Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall. Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or...

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Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals

July 6, 2017

Audience: Patient, Pharmacy. [Posted 07/06/2017] ISSUE: Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high...

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Ultra-Sten and D-Zine Capsules by Hardcore Formulations: Recall - Contains Anabolic Steroids

July 6, 2017

Audience: Consumer. [Posted 07/06/2017] ISSUE: Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them...

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Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance

June 27, 2017

Audience: Pharmacy. [Posted 06/27/2017] ISSUE: PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira prod...

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