Drug recall
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical…
FDA recall event 69413 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Key facts
| Event ID | 69413 |
|---|---|
| Recall numbers | D-0049-2015 |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc. |
| Product type | Drugs |
| Products | Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for… |
| Initiation date | Oct 21, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Apr 3, 2017 |
| City | Hawthorne |
| State | NY |
| Country | United States |
| FEI number | 2435212 |
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: