Reported Apr 13, 2022 · Terminated

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc.,…

Mylan Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc · 3711 Collins Ferry Rd · Morgantown, WV · 26505-2362

Is this the product you have?

  • Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only
  • Manufactured forMylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32
Lot codes and dates
    • Lot # TV11W101
    • Exp Mar 2023
Amount recalled
20,112 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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 product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 27, 2023 · Data as of Sep 19, 6:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.