Why it was recalled
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Product description
Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.
Lot numbers, UPCs & expiration codes
Lot 1113661 Exp. 01/15
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-1064-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 13, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 3,950 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Forest Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1064-2014, 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 1113661 Exp. 01/15
- Postal code
- 63045
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1064-2014
- Classification
- Class III
- Recalling firm
- Forest Pharmaceuticals Inc
- Product quantity
- 3,950 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), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Nov 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2014