D-0566-2022 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
173,499 bottles

Product Description

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

Reason for Recall

cGMP Deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: a) 19B081A, Exp. Date 02/2022; 19E088A, 19E089A, Exp. Date 05/2022 b) 19A102B, Exp. Date 02/2022; 19D067B, 19D068B, Exp. Date 04/2022; 19D070C, Exp. Date 05/2022. c) 19F045C, 19F046C, Exp. Date 06/2022; 19B082C, 19B083C, Exp. Date 03/2022; 19D069C, Exp. Date 05/2022.