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Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsul...

FDA Recall #D-1064-2014 — Class III — November 13, 2013

Recall #D-1064-2014 Date: November 13, 2013 Classification: Class III Status: Terminated

Product Description

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.

Recalling Firm

Forest Pharmaceuticals Inc — Earth City, MO

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,950 packs

Distribution

Nationwide and Puerto Rico.

Code Information

Lot 1113661 Exp. 01/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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