Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054…
Reason Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
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 CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
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