Drug recall
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India…
FDA recall event 89259 · Class II · Ascend Laboratories, LLC
Key facts
| Event ID | 89259 |
|---|---|
| Recall numbers | D-0359-2022 |
| Recalling firm | Ascend Laboratories, LLC |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed impurities/degradation specifications |
| Initiation date | Dec 21, 2021 |
| Report date | Jan 12, 2022 |
| Termination date | Apr 13, 2023 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3004459274 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: