Drug recall
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal…
FDA recall event 93976 · Class II · Amneal Pharmaceuticals of New York, LLC
Key facts
| Event ID | 93976 |
|---|---|
| Recall numbers | D-0426-2024 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Product type | Drugs |
| Products | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed dissolution specifications |
| Initiation date | Dec 26, 2023 |
| Report date | Apr 3, 2024 |
| Termination date | Aug 16, 2024 |
| City | Brookhaven |
| State | NY |
| Country | United States |
| FEI number | 3005263655 |
At a glance
- 1–9 Products in this recall
- 10–99 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: