Drug product
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
D-0553-2023
Product summary
- Event
- Event 91944
- Status
- Ongoing
- Classification
- Class II
- Quantity
- a)164 bottles; b) 198 bottles
- Official record key
drug-enforcement:D-0553-2023
Official wording
Reason: CGMP Deviations
Code information: a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations