Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
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 CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
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