Drug product
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
D-0160-2023
Product summary
- Event
- Event 91142
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,640 bottles
- Official record key
drug-enforcement:D-0160-2023
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023)
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications