D-1064-2014 Class III Terminated
FDA drug recall D-1064-2014 was initiated by Forest Pharmaceuticals Inc on November 13, 2013 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. The recall status is terminated (terminated May 7, 2014). Affected quantity: 3,950 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- November 13, 2013
- Termination Date
- May 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,950 packs
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.
Reason for Recall
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot 1113661 Exp. 01/15