Recalls / Class II
Class IID-0507-2023
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.
- Affected lot / code info
- Lot: 11AP2219 Exp. 4/30/23
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
- 20 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-0507-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.