Drug product
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
D-0642-2022
Product summary
- Event
- Event 89656
- Status
- Terminated
- Classification
- Class II
- Quantity
- 276 bottles
- Official record key
drug-enforcement:D-0642-2022
Official wording
Reason: CGMP deviations
Code information: Lot #s: a) G2919M, I0619O, F1419J; b) H3019Q; c) F1219N, F1919D, H0219D, I0519R, J0319G, Exp. 03/31/2022.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP deviations