FDA recall D-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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2013-11-13

Report date

2014-02-12

Termination date

2014-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Earth City, MO, United States

Primary source

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