Drug product
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
D-0564-2022
Product summary
- Event
- Event 89556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 73,920 bottles
- Official record key
drug-enforcement:D-0564-2022
Official wording
Reason: cGMP Deviations
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
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations