FDA-Drug2014-02-12Class III

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.

Forest Pharmaceuticals Inc
Hazard

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Sold states
Nationwide and Puerto Rico.
Affected count
3,950 packs
Manufactured in
13600 Shoreline Dr, Earth City, MO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1064-2014

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