Recalls / Class III
Class IIID-1262-2020
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
- Brand name
- Memantine Hydrochloride
- Generic name
- Memantine Hydrochloride
- Active ingredient
- Memantine Hydrochloride
- Route
- Oral
- NDCs
- 0904-6734, 0904-6736, 0904-6737, 0904-6735
- FDA application
- ANDA206028
- Affected lot / code info
- Lot #: M02199D, M02246D, Exp 5/2020
Why it was recalled
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, N/A, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 678 cartons
- Distribution pattern
- AL, FL, IA, NY, OH, TX
Timeline
- Recall initiated
- 2020-04-24
- FDA classified
- 2020-05-13
- Posted by FDA
- 2020-05-20
- Terminated
- 2022-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1262-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.