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., Parsippany, NJ 07054, USA. NDC: 64679-736-02.

FDA recall notice · announced June 4, 2014 · Wockhardt

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

The product

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., Parsippany, NJ 07054, USA. NDC: 64679-736-02.

Reason for recall

Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

Notes

Distribution: Nationwide.
Lot/code information: Lot #: LN11423, Expiry: 8/15/15
Quantity: 8712 Bottles
Status: Terminated
Products in this recall event:
- 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., Parsi (D-1355-2014)

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