The Recall Desk

FDA (Drugs) recall action 73474

Actavis Elizabeth LLC recalled 4 products on 2016-04-13

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-04-13
Critical
0
Units
593,019

Why these products were recalled

Failed Impurities/Degradation Specifications: Out of specification for impurities.

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.

1–4 of 4

  • SevereFDA (Drugs)··2016-04-13

    Actavis Recalls Amphetamine Tablets Due to Impurity Failures

    Actavis is recalling specific lots of amphetamine tablets because they failed impurity specifications. Consumers should stop using the product and contact their pharmacist.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 182,378 bottles of 30 mg Dextroamphetamine and Amphetamine tablets because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2016-04-13

    Actavis Recalls Dextroamphetamine Tablets for Impurity Failures

    Actavis is recalling specific lots of 10 mg dextroamphetamine tablets because they failed impurity specifications. The recall covers 114,388 bottles distributed nationwide.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Distribution
    0 states