Why it was recalled
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Product description
Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.
Lot numbers, UPCs & expiration codes
Lot 1112467 Exp. 02/15
Where it was sold
Nationwide and Puerto Rico.
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-1065-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 13, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 111,384 sample packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Forest Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1065-2014, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 66838
- Address
- 13600 Shoreline Dr
- Code information
- Lot 1112467 Exp. 02/15
- Postal code
- 63045
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1065-2014
- Classification
- Class III
- Recalling firm
- Forest Pharmaceuticals Inc
- Product quantity
- 111,384 sample packs
- Termination date
- May 7, 2014
- Reason for recall
- Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Nov 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2014