Drug product
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
D-0978-2018
Product summary
- Event
- Event 80454
- Status
- Terminated
- Classification
- Class III
- Quantity
- 28,436 bottles
- Official record key
drug-enforcement:D-0978-2018
Official wording
Reason: Subpotent Drug
Code information: Lot #: 2007979, Exp. 11/30/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent