FDA Drug recall D-0359-2022
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Labor…
- FDA Drug
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Labor… by Ascend Laboratories, citing failed impurities/degradation specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0359-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-21 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
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
Failed impurities/degradation specifications
Identifiers
| ndc | 67877-584-50 |
|---|---|
| ndc | 67877-584-01 |
| ndc | 67877-584-05 |
| ndc | 67877-584-33 |
| code_info | Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp…Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0359-2022%22
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