Drug Recall: Non-Sterile Lubricant Eye Drops Distributed Nationwide
Rite Aid is recalling lubricant eye drops due to non-sterility concerns. All lots of the Carboxymethylcellulose Sodium 0.5% product are affected.
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 for non-sterile eye drops indicates serious hazard potential. Although no illnesses have been reported, non-sterility poses a significant risk of eye infection.
Plain-English summary
Rite Aid is recalling lubricant eye drops (Carboxymethylcellulose Sodium 0.5%) packaged in 0.5 FL OZ (15mL) twin pack bottles due to non-sterility concerns. The product was manufactured by Kilitch Healthcare India Limited and distributed nationwide within the United States. All lot numbers are included in this recall. Approximately 6,024 bottles have been distributed.
The recall was initiated by the manufacturer on November 13, 2023, and classified as FDA Class I on February 5, 2024. This is a voluntary, firm-initiated recall. Non-sterile eye drops pose a serious risk to eye health. Consumers who have purchased this product should stop using it.
The recalled product
- Product
- LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Eye Drops
- Hazard
- Affected units
- 6,024
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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