Drug product
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
D-0477-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 91921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 bottles
- Official record key
drug-enforcement:D-0477-2023
Official wording
Reason: cGMP deviations
Code information: Lot, expiry: 19AU2205, exp 12/31/24; 12OC2211, exp 12/31/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations