Travoprost Ophthalmic Solution, 0.004% Solution/ Drops
FDA Recall NDC 0378-9651
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Travoprost Ophthalmic Solution, 0.004% (NDC 0378-9651). A significant event, classified as Class II, was initiated on Apr 01, 2022 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
April 2022 Class II Recall: Subpotent Drug and Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
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.
Apr 01, 2022
Apr 13, 2022
20,112 bottles
Recall Profile & Regulatory Data
Event ID
89906
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Feb 27, 2023
Product Description
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
0378-9651-32Product
0378-9651-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
