FDA-Drug2022-04-13Class II

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.

Mylan Pharmaceuticals Inc
Hazard

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.

Sold states
Nationwide in the USA and Puerto Rico
Affected count
20,112 bottles
Manufactured in
3711 Collins Ferry Rd, Morgantown, WV, United States
Products
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0748-2022

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