Reported Feb 12, 2014 · Terminated
Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in…
Forest Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Forest Pharmaceuticals Inc · 13600 Shoreline Dr · Earth City, MO · 63045
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 1113661 Exp. 01/15
- Amount recalled
- 3,950 packs
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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