Home Recalls D-0359-2022
Class II · Moderate risk Terminated Initiated Dec 21, 2021 (5 years ago)
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed impurities/degradation specifications
What was recalled
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
Recalling firm Ascend Laboratories, LLC
NDC code 67877-584-50
Origin NJ, United States
Initiated by Voluntary: Firm initiated
FDA recall number D-0359-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Class II · Moderate risk Terminated Aug 21, 2024
Reason Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class II · Moderate risk Terminated May 30, 2024
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated Jan 3, 2024
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated Dec 29, 2021
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated Nov 3, 2021
Reason Failed Impurities/Degradation Specifications