Mylan recalls Travoprost Ophthalmic Solution 0.004% 2.5mL bottles due to subpotent drug levels and impurities. This may affect prescription eye drops for glaucoma treatment.
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.
Mylan is recalling Travoprost Ophthalmic Solution 0.004% 2.5mL bottles because testing showed the drug concentration was too low and impurities were present. This could lead to ineffective treatment for glaucoma if used without replacement.
The drug concentration was too low (subpotent) and impurities were found during stability testing. This means the medication may not work properly for glaucoma treatment.
Prescription holders of Travoprost Ophthalmic Solution 0.004% 2.5mL bottles. People with glaucoma who rely on this medication are most at risk of ineffective treatment.
Check for the 2.5mL bottle labeled 'Travoprost Ophthalmic Solution, USP, 0.004%' with NDC 0378-9651-32. The lot number TV11W101 was manufactured in Morgantown, WV.
Identify the product by checking the bottle size, label, and NDC number.
The recall is due to subpotent drug levels and impurities, which could lead to ineffective treatment for glaucoma, but it does not indicate immediate danger to health.
The recall does not specify a stop-use instruction, so you can continue using it if you have a prescription.
Check for the NDC number 0378-9651-32 and lot number TV11W101 on the bottle label.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0748-2022 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0748-2022 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
