Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
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 .
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
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