Adverse Events and Recalls

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.

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.

September 11, 2019

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

August 29, 2019

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

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.

May 17, 2019

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

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.

May 02, 2019

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

April 15, 2019

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

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.