D-0564-2022 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
73,920 bottles

Product Description

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

Reason for Recall

cGMP Deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: a) 19C003A, Exp. Date 03/2022; 19G002A, exp. date 07/2022; b) 19C004B, Exp. Date 03/2022; c) 19C048C, Exp. Date 03/2022