Drug recall
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count…
FDA recall event 82617 · Class II · Dr. Reddy's Laboratories, Inc.
Key facts
| Event ID | 82617 |
|---|---|
| Recall numbers | D-1133-2019 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Product type | Drugs |
| Products | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. |
| Initiation date | Apr 11, 2019 |
| Report date | Apr 24, 2019 |
| Termination date | Jun 25, 2020 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003989912 |
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: