Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed…
Reason Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.
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: Low stage 3 results obtained for dissolution during routine stability testing.
Reason Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
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