FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility
CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification. The severity rubric identifies FDA Class I as a criterion for Critical rating. Non-sterility in ophthalmic products poses a significant risk of microbial contamination and potentially serious eye infections.
Plain-English summary
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, are being recalled. The product is distributed by CVS Pharmacy Inc. and was manufactured by Kilitch Healthcare India Limited.
The recall was initiated due to non-sterility of the product. Non-sterile eye drops pose a risk of microbial contamination, which could lead to serious eye infections.
The recall affects all lots of 45,408 bottles that were distributed nationwide within the United States. The recall was voluntarily initiated by the manufacturer and was classified by the FDA as Class I, indicating a serious potential health risk.
Consumers who have purchased this product should discontinue use immediately and dispose of it safely. Contact CVS Pharmacy or a healthcare provider for further guidance, especially if you have experienced any eye discomfort or infection after using this product.
The recalled product
- Product
- CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 45,408
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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