Recalls / Class II
Class IID-0478-2023
Product
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Affected lot / code info
- Lot, expiry: 21JU2210, exp 7/31/23
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 9 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-13
- FDA classified
- 2023-03-24
- Posted by FDA
- 2023-04-05
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0478-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.