Prescription Eye Drop Medication Recalled for Subpotency and Contamination
Mylan Pharmaceuticals recalls one lot of Travoprost ophthalmic solution due to subpotency and impurity issues found during stability testing. Patients should consult their pharmacist or physician if they have medication from this lot.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where no illnesses or injuries have been reported. Subpotent glaucoma medication could compromise treatment effectiveness and potentially lead to vision loss. The hazard is concrete and verified through quality testing.
Plain-English summary
Mylan Pharmaceuticals Inc. has recalled one lot of Travoprost Ophthalmic Solution, USP 0.004%, a prescription medication used to treat elevated eye pressure and glaucoma. The recall affects 20,112 bottles of lot TV11W101 (expiration date March 2023), distributed nationwide in the United States and Puerto Rico.
During routine stability testing, the medication failed quality specifications in two critical ways: the active ingredient concentration was found to be below the specified level (subpotent), and the product contained higher-than-acceptable levels of impurities and degradation byproducts. These quality failures could compromise the medication's effectiveness in treating the patient's eye condition.
Patients currently taking this medication should not stop their treatment without consulting their pharmacist or physician, as untreated elevated eye pressure can lead to vision loss. Patients with bottles from lot TV11W101 should contact their pharmacy to determine if they have affected medication and discuss alternative treatment options.
The FDA classified this recall as Class II. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- TRAVOPROST OPHTHALMIC SOLUTION, 0.004% (TRAVOPROST OPHTHALMIC SOLUTION, 0.004%)
- Brand
- TRAVOPROST OPHTHALMIC SOLUTION, 0.004%
- Manufacturer
- Mylan Pharmaceuticals Inc
- Category
- Drug — Ophthalmic
- Hazard
- subpotency
- impurities
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # TV11W101
- Exp Mar 2023
Distribution
Distributed nationwide across the United States.
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