The Recall Desk

FDA (Drugs) recall action 66838

Forest Pharmaceuticals Inc recalled 3 products on 2014-02-12

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-02-12
Critical
0
Units
115,490

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··2014-02-12

    Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures

    Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.

    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.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    Forest Pharmaceuticals Recalls Namenda XR Capsules for Dissolution Failures

    Forest Pharmaceuticals is recalling 156 bottles of Namenda XR 7 mg capsules because they failed stability dissolution testing. The affected product was distributed nationwide and in Puerto Rico.

    Product
    Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2014-02-12

    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.

    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.
    Category
    Distribution
    1 state