Drug product
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
D-0568-2022
Product summary
- Event
- Event 89556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,477 bottles
- Official record key
drug-enforcement:D-0568-2022
Official wording
Reason: cGMP Deviations
Code information: Lot #: 19B064A, Exp. Date 03/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations