FDAClass IIJune 4, 2014

Metoprolol Succinate Extended-Release Tablets recall: Failed Dissolution

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.

Why was Metoprolol Succinate Extended-Release Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: LN11423, Expiry: 8/15/15

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.
Recalling firm
Wockhardt Usa Inc.
Quantity
8712 Bottles
Distribution
Nationwide.
Recall date
June 4, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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