Adverse Events and Recalls

WuXi Biologics Provides Update on Operations in Light of Coronavirus Outbreak

February 14, 2020

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.

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

December 12, 2019

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.

Adverse Event Reporting for Compounded Drugs

September 11, 2019

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

FDA Expands Scope of API Impurity Investigation

August 29, 2019

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

Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

May 30, 2019

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.

FDA Accepts TraceLink DSCSA Pilot Submission

May 17, 2019

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

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

May 03, 2019

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

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

May 02, 2019

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

EMA Reviews Safety of Alemtuzumab

April 15, 2019

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

Federal Court Enters Consent Decree Against Compounder

February 07, 2019

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.