The Recall Desk

FDA (Drugs) recall action 63926

Amedra Pharmaceuticals LLC recalled 3 products on 2013-03-06

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
2013-03-06
Critical
0
Units
25,092

Why these products were recalled

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

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)··2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
    Category
    Distribution
    1 state