April 2022 FDA Recall Travoprost Ophthalmic Solution, 0.004% by Mylan Pharmaceuticals Inc
D-0748-2022 - Subpotent Drug and Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc on April 1, 2022 for the product Travoprost Ophthalmic Solution, 0.004%. The FDA reported the reason for recall as subpotent drug and failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0748-2022

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.
Initiated
04-01-2022
Reported
04-13-2022
Quantity
20,112 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89906
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# TV11W101, Exp Mar 2023

Affected Packages Involved in this Recall

0378-9651-32 Travoprost Ophthalmic Solution, 0.004%
0378-9651-50 Travoprost Ophthalmic Solution, 0.004%