Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Bo

FDA recall notice · announced August 27, 2014 · Wockhardt

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA

Reason for recall

Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

Notes

Distribution: Nationwide
Lot/code information: Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
Quantity: 11,661 HDPE bottles
Status: Terminated
Products in this recall event:
- Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, (D-1541-2014)

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