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 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
Lot numbers, UPCs & expiration codes
Lot# M02465D
Where it was sold
U.S.A. Nationwide
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-0844-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 13, 2019
- FDA report date
- Feb 26, 2020
- Quantity
- 246 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0844-2020, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 84955
- Address
- 17177 N Laurel Park Dr Ste 233
- Code information
- Lot# M02465D
- Postal code
- 48152-3951
- Report date
- Feb 26, 2020
- Product type
- Drugs
- Recall number
- D-0844-2020
- Classification
- Class III
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 246 Cartons
- Termination date
- Nov 4, 2020
- 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 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 14, 2020