Drug product
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
D-0654-2022
Product summary
- Event
- Event 89712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 401 bottles
- Official record key
drug-enforcement:D-0654-2022
Official wording
Reason: CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Code information: Lot #: GS027852, Expiry: 06/2022.
Distribution pattern: Distributed to 1 wholesaler/distributor
Derived failure modes
-
Manufacturing or process control
CGMP Deviation