ANI Pharmaceuticals, Inc. — Class II Recall

Product

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

cGMP Deviations

Classification

Class II

Status

Terminated

Lot

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.

Date

2022-02-23

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.