The Recall Desk

FDA (Drugs) recall action 89556

ANI Pharmaceuticals, Inc. recalled 5 products on 2022-02-23

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2022-02-23
Critical
0
Units
529,346

Why these products were recalled

cGMP Deviations

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.

1–5 of 5

  • ModerateFDA (Drugs)··2022-02-23

    Alprazolam Tablets USP 1.0 mg Recalled for cGMP Deviations

    ANI Pharmaceuticals has recalled Alprazolam Tablets USP 1.0 mg distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 173,499 bottles across multiple lot numbers.

    Product
    Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-23

    Alprazolam Tablets USP 0.25 mg Recalled for cGMP Deviations

    ANI Pharmaceuticals is recalling Alprazolam Tablets USP 0.25 mg nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects multiple lot numbers of 100-count, 500-count, and 1000-count bottles distributed across the United States.

    Product
    Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-23

    Pyrazinamide Tablets 500 mg Recalled Due to cGMP Deviations

    ANI Pharmaceuticals, Inc. has recalled Pyrazinamide Tablets USP 500 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5,477 bottles distributed nationwide.

    Product
    Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-23

    Alprazolam Tablets 2.0 mg Recalled for cGMP Deviations

    ANI Pharmaceuticals is recalling Alprazolam Tablets, USP 2.0 mg nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 70,788 bottles distributed throughout the United States.

    Product
    Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-23

    Alprazolam Tablets 0.5 mg Recalled Due to cGMP Deviations

    ANI Pharmaceuticals is voluntarily recalling Alprazolam Tablets USP 0.5 mg in multiple package sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 205,662 bottles distributed across the United States.

    Product
    Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
    Category
    Distribution
    0 states