CVS Health Lubricating Gel Drops Recalled Due to Non-Sterility
CVS Health brand Lubricating Gel Drops are being recalled due to non-sterility concerns. The voluntary recall affects approximately 110,832 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 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: FDA Class I classification mandates a minimum severity score of 4. Non-sterility in ophthalmic products presents a serious risk of bacterial contamination and eye infection. No reported illnesses, serious injuries, or deaths are documented in the source material, preventing a Critical rating.
Plain-English summary
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, are being recalled. The product was manufactured by Kilitch Healthcare India Limited and distributed by CVS Pharmacy Inc. under NDC 76168-712-10. All lots of the product are affected by this recall.
The recall was initiated due to non-sterility. Non-sterile eye drops can allow bacterial contamination and pose a risk of eye infection. The FDA classified this as a Class I recall, indicating a serious potential health hazard.
Approximately 110,832 bottles have been distributed nationwide within the United States. This is a voluntary recall initiated by the manufacturer.
Consumers who have purchased this product should stop using it immediately. If you have used this product and experienced eye irritation, infection, or other adverse effects, contact your healthcare provider.
The recalled product
- Product
- CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic
- Affected units
- 110,832
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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