Quality/GMPs

Articles

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

WuXi Biologics Provides Update on Operations in Light of Coronavirus Outbreak

According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.

FDA Releases Statement Regarding the Recall of Basic Reset and Biogenyx Products

FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

Adverse Event Reporting for Compounded Drugs

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

FDA Expands Scope of API Impurity Investigation

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected. 

Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act. 

FDA Accepts TraceLink DSCSA Pilot Submission

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

Par Pharmaceutical, Inc. Recalls Mycophenolate Mofetil for Injection, USP

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

Sagent Pharmaceuticals, Inc. Recalls Ketorolac Tromethamine Injection, USP, 60mg/2mL

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

EMA Reviews Safety of Alemtuzumab

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

Adverse Events and Recalls