Drug product
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
D-0161-2023
Product summary
- Event
- Event 91142
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20,040 bottles
- Official record key
drug-enforcement:D-0161-2023
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications