Forest Pharmaceuticals Recalls Namenda XR Sample Packs for Dissolution Failures
Forest Pharmaceuticals is recalling Namenda XR sample packs because they failed stability dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a failure in dissolution specifications, a quality control defect, with no reported injuries or illnesses.
Plain-English summary
Forest Pharmaceuticals Inc. is recalling 111,384 sample packs of Namenda XR (memantine HCl) 28 mg extended-release capsules. The product is packaged in 5-count sample packs and is prescription-only. The recall involves Lot 1112467 with an expiration date of 02/15.
The recall was initiated because three lots of the product failed stability dissolution testing. This means the medication may not release the active ingredient as intended over time.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- 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.
- Manufacturer
- Forest Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 111,384
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1112467 Exp. 02/15
Distribution
Part of a larger recall action
This product is one of 3 recalled by Forest Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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- LowForest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures
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