Recalls / Class III
Class IIID-1064-2014
Product
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.
- Affected lot / code info
- Lot 1113661 Exp. 01/15
Why it was recalled
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Recalling firm
- Firm
- Forest Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13600 Shoreline Dr, Earth City, Missouri 63045
Distribution
- Quantity
- 3,950 packs
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2013-11-13
- FDA classified
- 2014-02-04
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1064-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.