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. Pars

FDA recall notice · announced December 24, 2014 · Wockhardt

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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 .

Reason for recall

Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Notes

Distribution: Nationwide.
Lot/code information: a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
Quantity: 1,118,400 extended release tablets
Status: Terminated
Products in this recall event:
- 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 Di (D-0304-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.