Drug product
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
D-0748-2022
Product summary
- Event
- Event 89906
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,112 bottles
- Official record key
drug-enforcement:D-0748-2022
Official wording
Reason: Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Code information: Lot # TV11W101, Exp Mar 2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent