Why it was recalled
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Product description
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Lot numbers, UPCs & expiration codes
Lot #: H901787, H901788, Exp March 2021
Where it was sold
Nationwide in the USA
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-0629-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 10, 2019
- FDA report date
- Dec 25, 2019
- Quantity
- 3,726 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0629-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84463
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: H901787, H901788, Exp March 2021
- Postal code
- 21202-6174
- Report date
- Dec 25, 2019
- Product type
- Drugs
- Recall number
- D-0629-2020
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 3,726 bottles
- Termination date
- Apr 29, 2021
- Reason for recall
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 10, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2019