Drug recall
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem…
FDA recall event 78786 · Class II · Unichem Pharmaceuticals Usa Inc
Key facts
| Event ID | 78786 |
|---|---|
| Recall numbers | D-0228-2018 |
| Recalling firm | Unichem Pharmaceuticals Usa Inc |
| Product type | Drugs |
| Products | Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium. |
| Initiation date | Dec 19, 2017 |
| Report date | Jan 24, 2018 |
| Termination date | Sep 12, 2018 |
| City | Hasbrouck Heights |
| State | NJ |
| Country | United States |
| FEI number | 3007525397 |
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: