The Recall Desk

FDA (Drugs) recall action 86584

ANI Pharmaceuticals, Inc. recalled 6 products on 2020-10-28

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2020-10-28
Critical
0
Units
93,912

Why these products were recalled

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

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.

1–6 of 6

  • LowFDA (Drugs)··2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling 34,968 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling 13,248 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling 408 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Distribution
    0 states