Adverse Events and Recalls

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.

The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.

The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.

The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

With minimal damage to its manufacturing plant in Humacao, Puerto Rico, Colorcon has been able to restore full operations.

The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.

The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.

GlaxoSmithKline has issued a voluntary recall of three lots of respiratory inhalers in the United Kingdom, including preventer and emergency relief inhalers.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.

FDA and CDC are investigating a multi-state Salmonella outbreak that appears to be caused by kratom, a plant used as an opioid substitute.

The company is voluntarily recalling one lot of Acyclovir Tablet due to packaging that may contain a different product.

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

The company is voluntarily recalling product because of glass particles found in vials.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

The company is recalling product because of microbial contamination.

The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.