FDA Recall D-0509-2023
Direct Rx · Dawsonville, GA
Class II Ongoing 1149 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Recall record
- Recall number
D-0509-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-03-22
- Classified by FDA Center
- 2023-04-06
- FDA published
- 2023-04-12
- Recalling firm
- Direct Rx
- Firm location
- Dawsonville, GA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.