Wockhardt Metoprolol Succinate recall: Failed Dissolution
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Why was Wockhardt Metoprolol Succinate recalled?
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing 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?
a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
- Product
- Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
- Recalling firm
- Wockhardt Usa Inc.
- Quantity
- 1,118,400 extended release tablets
- Distribution
- Nationwide.
- Recall date
- December 24, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)