Recall: D-1262-2020

Class III - Minor Violations

Class IIIClassification

2020-04-24Initiated

TerminatedStatus

The Harvard Drug GroupFirm

Product

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

Reason

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

Distribution

AL, FL, IA, NY, OH, TX

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