Gentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
Sterling Pharmaceutical Services LLC is recalling Gentle Eyes Lubricant Eye Drops due to a lack of assurance of sterility.
What this means for you
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: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Sterling Pharmaceutical Services LLC is recalling 14,538 bottles of Gentle Eyes Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%). The product is a sterile ophthalmic solution manufactured exclusively for TRP Company, Inc. The recall is being conducted because of a lack of assurance of sterility.
The affected product is distributed nationwide in the United States. The recall includes two specific lots: Lot # 3279 with an expiration date of 6/30/2027, and Lot # 3292 with an expiration date of 5/31/2027. The product is identified by NDC 17312-430-15.
Consumers who have purchased this product should check their bottles for the lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- GENTLE EYES LUBRICANT EYE DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- GENTLE EYES LUBRICANT EYE DROPS
- Manufacturer
- Sterling Pharmaceutical Services LLC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 14,538
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 (4)
- Lot # 3279
- Exp 6/30/2027
- Lot # 3292
- Exp 5/31/2027.
Distribution
Distributed nationwide across the United States.
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