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.

Recall Number: D-0568-2022

Firm: ANI Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220223

Initiation Date: 20220215

Termination Date: 20221025

cGMP Deviations

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.