Drug recall
Topiramate Tablets, 200 mg, Lot # 16T020, exp. 1/2012, NDC 0093-7220-06 (60 count). Teva Pharmaceuticals USA…
FDA recall event 60763 · Class II · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 60763 |
|---|---|
| Recall numbers | D-1225-2012, D-1226-2012 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Topiramate Tablets, 200 mg, Lot # 16T020, exp. 1/2012, NDC 0093-7220-06 (60 count). Teva Pharmaceuticals USA, Inc. Sellersville, PA, Topiramate Tablets, 25 mg, Lot # 28T027, exp. 1/2012, NDC 0093-0155-10 (1000 count) and Lot # 28T030, exp. 1/2012, NDC 0093-0155-06 (60 count). Teva Pharmaceuticals USA, Inc. Sellersville, PA |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: High OOS results for Impurity. |
| Initiation date | Dec 22, 2011 |
| Termination date | Oct 5, 2012 |
| City | Sellersville |
| State | PA |
| Country | United States |
| FEI number | 2517175 |
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