Drug product
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
D-0507-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 92054
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 bottles
- Official record key
drug-enforcement:D-0507-2023
Official wording
Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Code information: Lot: 11AP2219 Exp. 4/30/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations