Unlikely to cause harm — often a labeling or packaging issue.
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
| Distributed by / for | Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA |
| NDC | 64679-735-02 |
| Full product label | Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA . |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | Nationwide. |
| Quantity | 1,118,400 extended release tablets |
| Recall initiated | 2014-04-17 |
| Report date | 2014-12-24 |
| Recall completed | 2015-08-13 |
| Recall number | D-0304-2015 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗