Recall: D-0844-2020

Class III - Minor Violations

Class IIIClassification

2019-12-13Initiated

TerminatedStatus

The Harvard Drug GroupFirm

Product

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.

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.