Eye allergy medication recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.
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: FDA Class II mandatory recall for an out-of-specification impurity in an ophthalmic product. The failed stability test indicates a potential risk-of-harm in a medication applied directly to sensitive eye tissue.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Clear Eyes, Once Daily, Eye Allergy Itch Relief (olopatadine hydrochloride ophthalmic solution, USP, 0.2%) due to a failed impurities specification. During stability testing, an out-of-specification result was obtained for an unspecified impurity.
The recall affects 715,632 bottles distributed nationwide in the United States. The product was manufactured in Israel and distributed by Medtech Products Inc, a Prestige Consumer Healthcare company, located in Tarrytown, NY. Affected lot numbers are #114349 (Exp. 05/2023), #117396 (Exp. 09/2023), #120128 (Exp. 11/2023), #114371 (Exp. 06/2023), and #123781 (Exp. 02/2024).
Consumers using the affected product should stop use and contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 67
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Ophthalmology / Eye Drops
- Hazard
- impurity
- out-of-specification
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 (10)
- Lot #114349
- Exp. 05/2023
- 117396
- Exp. 09/2023
- 120128
- Exp. 11/2023
- 114371
- Exp. 06/2023
- 123781
- Exp. 02/2024.
Distribution
Distributed nationwide across the United States.
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