FDAFDA · Food and drugs·Recall number D-1064-2014
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.
Published February 12, 2014 · Recall initiated: November 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Forest Pharmaceuticals Inc
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot 1113661 Exp. 01/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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