Drug recall
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured…
FDA recall event 90680 · Class II · Amneal Pharmaceuticals of New York, LLC
Key facts
| Event ID | 90680 |
|---|---|
| Recall numbers | D-1362-2022 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Product type | Drugs |
| Products | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed dissolution specifications. |
| Initiation date | Jul 27, 2022 |
| Report date | Aug 31, 2022 |
| Termination date | Aug 17, 2023 |
| 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: