FDA Alert: Clear Eyes Eye Drops Recalled Over Contamination Concerns
Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops are being pulled from store shelves nationwide due to sterility concerns, according to an enforcement report issued by the U.S. Food and Drug Administration. Prestige Brand Holdings, a consumer healthcare company based in Tarrytown, New York, initiated the voluntary recall because of a lack of assurance regarding product sterility.
National Recall Pulls Nearly 40,000 Bottles of Eye Drops
Class II Designation Covers Specific 15mL Batch
The regulatory action affects a specific production batch distributed across the United States. According to the U.S. Food and Drug Administration enforcement report, the recall covers precisely 39,060 bottles of the over-the-counter ophthalmic formulation. The agency classified the event as a Class II recall. This designation applies to situations where exposure to a violative product may cause temporary or medically reversible adverse health consequences, establishing that the probability of serious harm remains remote.
- Prestige Brand Holdings voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops.
- The U.S. Food and Drug Administration classified the action as a Class II recall due to moderate health risks.
- Affected products are 15mL bottles featuring lot code 2552 and an expiration date of September 30, 2027.
Manufacturer Silent as Regulators Flag Sterility Breakdown
Consumer health company Prestige Brand Holdings markets and distributes a broad portfolio of over-the-counter medications, including Dramamine, Breathe Right nasal strips, and Monistat. The manufacturer did not immediately respond to a request for comment regarding the underlying sterility breakdown, as reported by USA TODAY.
Lot Code 2552 and Actionable Consumer Guidance
The affected merchandise consists of 15mL bottles bearing NDC number 67172-999-01 and UPC code 6 78112 65920 3. Every bottle in the recalled batch carries lot code 2552 and an expiration date of September 30, 2027. Federal regulators advise consumers who purchased these specific lots to immediately discontinue use.
Supply Chain Integrity and Patient Safety Priorities
Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.