Class II
Terminated
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
This recall has been terminated (originally issued August 27, 2014).
- Company
- Wockhardt Usa Inc.
- Recall Initiated
- July 24, 2014
- Posted
- August 27, 2014
- Recall Number
- D-1541-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,661 HDPE bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Distribution
Nationwide
Lot / Code Info
Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
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