FDA-Drug2014-02-12Class III

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.

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
111,384 sample packs
Manufactured in
13600 Shoreline Dr, Earth City, MO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1065-2014

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