Antibiotic Capsules Recalled

Ascend Laboratories is recalling 42,698 bottles of cefixime capsules because samples failed to meet impurity/degradation specifications during routine testing. The recall appeared in the January 12, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 50-count bottles of 400-mg cefixime capsules (NDC 67877-584-50) from lots 20140293 (Exp. 12/21); 20141525, 20141526, and 20141527 (Exp. 3/22); 20143019, 20143020, 20143021, and 20143022 (Exp. 7/22); and 20144759, 20144760, and 20144761 (Exp. 11/22). The capsules were manufactured by Alkem Laboratories Ltd., Mumbai, India, and distributed by Ascend Laboratories, LLC, Parsippany, NJ, throughout the United States.

Ascend Laboratories voluntarily initiated the recall December 21, 2021. On January 5, 2022, the FDA designated the recall Class II, communicating use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Cefixime is a prescription cephalosporin antibiotic used to treat a variety of bacterial infections.