Home / Recalls / ANI Pharmaceuticals, Inc. / D-0568-2022

D-0568-2022 Class II Terminated

Recalled by ANI Pharmaceuticals, Inc. — Baudette, MN

Recall Details

Product Type
Drugs
Report Date
February 23, 2022
Initiation Date
February 15, 2022
Termination Date
October 25, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,477 bottles

Product Description

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.

Reason for Recall

cGMP Deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 19B064A, Exp. Date 03/2022

Other recalls by ANI Pharmaceuticals, Inc.

  • D-0565-2022 Class II — Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901- (February 15, 2022)
  • D-0564-2022 Class II — Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900 (February 15, 2022)
  • D-0566-2022 Class II — Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902- (February 15, 2022)
  • D-0567-2022 Class II — Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903- (February 15, 2022)
  • D-0044-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0047-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0046-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0043-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0048-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)
  • D-0045-2021 Class III — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami (October 9, 2020)