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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- non-sterility
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.
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