D-0564-2022 Class II Terminated
FDA drug recall D-0564-2022 was initiated by ANI Pharmaceuticals, Inc. on February 15, 2022 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated October 25, 2022). Affected quantity: 73,920 bottles.
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