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

FDA recall notice · announced May 20, 2020 · The Harvard Drug Group

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

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

Notes

Distribution: AL, FL, IA, NY, OH, TX
Lot/code information: Lot #: M02199D, M02246D, Exp 5/2020
Quantity: 678 cartons
Status: Terminated
Products in this recall event:
- 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 Pharmaceut (D-1262-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.