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Nearly 40,000 bottles of Clear Eyes eye drops recalled over sterility concerns

Created at 22 Aug · 3:55 PM1 source↑ Market-relevant
IN SHORT

Prestige Brand Holdings is recalling 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops due to a lack of assurance of sterility. The FDA classified the recall as Class II, indicating a moderate risk.

Key Numbers

39,060bottles of eye drops recalled
15mlbottle size
September 30, 2027expiration date

Who's Involved

Prestige Brand Holdings
Company initiating voluntary recall of eye drops
Food and Drug Administration (FDA)
Agency classifying the recall as Class II
Medtech Products Inc
Distributor of the recalled eye drops

↳ Why This Matters

The recall of nearly 40,000 bottles of eye drops highlights ongoing concerns about product sterility in medicinal products, potentially impacting consumer health and trust in over-the-counter medications.

Key facts

  • Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops are being recalled.
  • The recall is due to concerns about potential contamination and a lack of assurance of sterility.
  • The affected product has lot code 2552A and an expiration date of September 30, 2027.
  • The FDA classified the recall as Class II, indicating a moderate risk.
  • Consumers should stop using the eye drops and return them for a refund.

Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops are being recalled across the United States due to concerns about potential contamination and a lack of assurance of sterility. Prestige Brand Holdings, the Tarrytown, New York-based company, voluntarily initiated the recall, which covers 39,060 bottles.

The U.S. Food and Drug Administration (FDA) has classified this action as a Class II recall. This classification signifies a moderate-risk situation where the use of the product might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The specific product affected by the recall is the 15ml bottle of Clear Eyes Maximum Itchy Eye Relief, identified by lot code 2552A and an expiration date of September 30, 2027. This product is distributed by Medtech Products Inc., a subsidiary of Prestige Consumer Healthcare.

Clear Eyes Maximum Itchy Eye Relief is marketed as a redness-reliever eye drop designed to alleviate symptoms such as redness, itching, burning, and watery eyes. It is sold at numerous major retailers, including Walmart, Target, Kroger, Giant Eagle, Meijer, Dollar General, and Family Dollar stores.

Consumers who have purchased the recalled eye drops are advised to discontinue their use immediately and return the product to the place of purchase for a refund. Individuals with concerns about potential health effects are encouraged to consult with a pharmacist or healthcare provider. The FDA noted that while less common than food safety issues, recalls of eye drops do occur, citing a 2023 recall of EzriCare Artificial Tears linked to a bacterial outbreak.

Frequently asked questions

The recall involves 15ml bottles of Clear Eyes Maximum Itchy Eye Relief eye drops with lot code 2552A and an expiration date of September 30, 2027.

The recall is due to a lack of assurance of sterility, indicating potential contamination.

The FDA classified this as a Class II recall, meaning there is a moderate risk of temporary or medically reversible adverse health consequences, with a remote probability of serious harm.

Consumers can return the recalled eye drops to the retailers where they were purchased for a refund.

What Happens Next

01Consumers should return recalled eye drops for a refund.
02Consumers with concerns should contact a healthcare provider.

How It Developed

Prestige Brand Holdings recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops.
The recall is due to a lack of assurance of sterility.
The FDA classified the recall as Class II, a moderate-risk situation.
Consumers are advised to stop using the product and return it for a refund.

Sources

T1
40,000 bottles of eye drops across the US recalled over issues with sterility of productThe Guardian

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