Recalls / Class II
Class IID-0509-2023
Product
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
- Affected lot / code info
- Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23
Why it was recalled
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 9 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-22
- FDA classified
- 2023-04-06
- Posted by FDA
- 2023-04-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0509-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.