Why it was recalled
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: M02199D, M02246D, Exp 5/2020
Where it was sold
AL, FL, IA, NY, OH, TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1262-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 24, 2020
- FDA report date
- May 20, 2020
- Quantity
- 678 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-1262-2020, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 85566
- Address
- 17177 N Laurel Park Dr Ste 233
- Code information
- Lot #: M02199D, M02246D, Exp 5/2020
- Postal code
- 48152-3951
- Report date
- May 20, 2020
- Product type
- Drugs
- Recall number
- D-1262-2020
- Classification
- Class III
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 678 cartons
- Termination date
- Aug 19, 2022
- Reason for recall
- Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AL, FL, IA, NY, OH, TX
- Recall initiation date
- Apr 24, 2020
- Initial firm notification
- Letter
- Center classification date
- May 13, 2020