Mylan Pharmaceuticals Inc recalls Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morga
Recalled April 13, 2022 · FDA recall D-0748-2022 · Mylan Pharmaceuticals
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. · FDA Class II
Units
20,112 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
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.
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.
Manufacturer(s)
Mylan Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →