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

Recall Number: D-0567-2022

Firm: ANI Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220223

Initiation Date: 20220215

Termination Date: 20221025

cGMP Deviations

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