Drug 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
D-0478-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 91921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 bottles
- Official record key
drug-enforcement:D-0478-2023
Official wording
Reason: cGMP deviations
Code information: Lot, expiry: 21JU2210, exp 7/31/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations