FDA Recall Terminated Historical recordClass III
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Published
- February 26, 2020
- Distribution
- Nationwide
