D-0567-2022 Class II Terminated
FDA drug recall D-0567-2022 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: 70,788 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
- 70,788 bottles
Product Description
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
Reason for Recall
cGMP Deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) 19C002A, Exp. Date 03/2022; 19E012A, 19E013A, Exp. Date 05/2022. b) 19C100B, Exp. Date 04/2022; 19E001B, 19E002B, Exp. Date 05/2022.