Why it was recalled
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Product description
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Lot numbers, UPCs & expiration codes
Lot #: H900330, exp. date 11/2020.
Where it was sold
Nationwide within the United States.
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-0855-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 6,294 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0855-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84948
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: H900330, exp. date 11/2020.
- Postal code
- 21202-6174
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0855-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 6,294 bottles
- Termination date
- Jun 3, 2021
- Reason for recall
- Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
- Distribution pattern
- Nationwide within the United States.
- Recall initiation date
- Feb 12, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 24, 2020