Drug recall
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind…
FDA recall event 88891 · Class III · UNICHEM PHARMACEUTICALS USA INC
Key facts
| Event ID | 88891 |
|---|---|
| Recall numbers | D-0255-2022 |
| Recalling firm | UNICHEM PHARMACEUTICALS USA INC |
| Product type | Drugs |
| Products | Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Discoloration |
| Initiation date | Oct 25, 2021 |
| Report date | Dec 1, 2021 |
| Termination date | Oct 12, 2022 |
| City | East Brunswick |
| State | NJ |
| Country | United States |
| FEI number | 3015297395 |
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: