FDAFDA · Food and drugs·Recall number D-0748-2022
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Published April 13, 2022 · Recall initiated: April 1, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TRAVOPROST OPHTHALMIC SOLUTION, 0.004%
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot # TV11W101, Exp Mar 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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