FDA Recalls Lubricant Eye Drops Due to Non-Sterility
Rite Aid is recalling all lots of Lubricant Gel Drops due to non-sterility concerns. The product was 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: This is an FDA Class I recall, which per the severity rubric requires a minimum score of 4 (Severe). Non-sterility in an ophthalmic product presents a direct health risk of infection.
Plain-English summary
Rite Aid is recalling all lots of Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 (NDC 11822-4540-3).
The recall was initiated due to non-sterility concerns. The product was classified as an FDA Class I recall, indicating a serious health hazard.
The recalled product was distributed nationwide throughout the United States. A total of 7,776 bottles across all lots were affected by this recall.
Consumers should discontinue use of this product. The manufacturer, Kilitch Healthcare India Limited, initiated this voluntary recall on November 13, 2023.
The recalled product
- Product
- Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- Affected units
- 7,776
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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