Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
FDA recall notice · announced November 17, 2021 · 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 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
Reason for recall
Failed Impurities/Degradation Specifications
Notes
Distribution: Nationwide
Lot/code information: Lot 20140282, exp Dec 2021
Quantity: 4104 bottles
Status: Terminated
Products in this recall event:
- Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584- (D-0229-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.