Enforcement Report - Week of August 25, 2021
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Two injected drugs manufactured by an Indian company with a history of sterility problems are being recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but are distributed in the U.S. by Heritage Pharmaceuticals.
Teva Pharmaceuticals today announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter.
US FDA Enforcement Report- 1/June/2016
Teva Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Amikacin Sulfate Injection USP 1 gram/4mL (250 mg/mL) Vials Due to Glass Particulate Matter
Fresenius Kabi`s Generic Amikacin sulfate (50mg) approved in US for Infections
Fresenius Kabi`s Generic Amikacin sulfate (250mg) approved in US for Infections
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.