Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

FDA recall notice · announced January 12, 2022 · Ascend Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

Reason for recall

Failed impurities/degradation specifications

Notes

Distribution: USA nationwide.
Lot/code information: Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22
Quantity: 42,698 bottles
Status: Terminated
Products in this recall event:
- Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50 (D-0359-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.