Prestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
Prestige Brands Holdings is recalling Clear Eyes Maximum Itchy Eye Relief eye drops due to a lack of assurance of sterility and potential contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility for an ophthalmic product, which carries a significant risk of serious injury or adverse health consequences if contaminated.
Plain-English summary
Prestige Brands Holdings is recalling 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief (Glycerin and Naphazoline Hydrochloride and Zinc Sulfate). The product is a 0.5 fl oz (15 mL) sterile ophthalmic solution distributed by Medtech Products Inc. in Tarrytown, NY. The specific lot affected is 2552A, with an expiration date of 09/30/2027.
The recall was initiated due to a lack of assurance of sterility, which poses a risk of potential contamination. The agency has classified this as a Class II recall. The product was distributed nationwide in the USA.
Consumers who have this product should stop using it and check their lot number and expiration date against the information provided. If the product matches the recalled lot, consumers should contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
- Manufacturer
- Prestige Brands Holdings
- Category
- Drug — Ophthalmic
- Hazard
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 2552A
- Exp 09/30/2027
Distribution
Distributed nationwide across the United States.
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