The Recall Desk

FDA (Drugs) recall action 73679

Impax Laboratories, Inc. recalled 2 products on 2016-04-27

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-04-27
Critical
0
Units
86,364

Why these products were recalled

Failed Impurities/Degradation Specifications

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.

1–2 of 2

  • SevereFDA (Drugs)··2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, because the product failed impurities and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling specific lots of Dextroamphetamine Sulfate Tablets because they failed impurity and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
    Category
    Distribution
    0 states