FDA Drug Class II — Moderate

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.

Hazard

Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

Products

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippa
Brand
Wockhardt Usa Inc.
UPC
Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15

Units Affected

109,744 bottles