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

FDA recall notice · announced May 14, 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, 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.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15
Quantity: 109,744 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1300-2014)

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