Drug product
TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378135201.
D-896-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-896-2014
Official wording
Reason: Labeling: Label Mixup: TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: AD30028_31, EXP: 5/8/2014.
Code information: TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mghas the following codes: Pedigree: AD28333_4, EXP: 5/6/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled