Drug product
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
D-0877-2018
Product summary
- Event
- Event 80261
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,620 bottles
- Official record key
drug-enforcement:D-0877-2018
Official wording
Reason: Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Code information: Lot #: 3087136, Exp 5/20
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Potency or specification failure
Superpotent