RecallDepth
Class II Terminated

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

Company
Mylan Pharmaceuticals Inc.
Recall Initiated
April 1, 2022
Posted
April 13, 2022
Recall Number
D-0748-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
20,112 bottles
Firm Location
Morgantown, WV, United States

Reason for Recall

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.

Distribution

Nationwide in the USA and Puerto Rico

Lot / Code Info

Lot # TV11W101, Exp Mar 2023

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