Drug recall
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by…
FDA recall event 68402 · Class II · Wockhardt Usa Inc.
Key facts
| Event ID | 68402 |
|---|---|
| Recall numbers | D-1355-2014 |
| Recalling firm | Wockhardt Usa Inc. |
| Product type | Drugs |
| Products | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. |
| Initiation date | Apr 10, 2014 |
| Report date | Jun 4, 2014 |
| Termination date | Aug 13, 2015 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3003060524 |
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: