Eye Lubricant Solution Recalled for Manufacturing Deviations and Sterility Concerns
BRS Analytical Services is recalling Carboxymethylcellulose Sodium 0.5% ophthalmic solution nationwide due to manufacturing practice deviations and inability to assure sterility. Multiple lot numbers are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with documented manufacturing deviations affecting a sterile ophthalmic product. While no illnesses or injuries have been reported, the inability to assure sterility poses a risk of harm through potential eye infections.
Plain-English summary
BRS Analytical Services, LLC is recalling Carboxymethylcellulose Sodium 0.5% ophthalmic solution (eye lubricant drops) distributed nationwide by AvKARE. The recall involves 32,876 cases encompassing multiple lot numbers with expiration dates ranging from April 2025 through February 2027.
The recall is due to current Good Manufacturing Practice (cGMP) deviations and the company's inability to provide assurance that the product meets sterility requirements. For an ophthalmic solution that must be sterile to prevent serious eye infections, this is a significant concern.
No illnesses or injuries have been reported to date. Consumers who have purchased affected lots should stop using the product and contact their healthcare provider or pharmacist if they have used it.
The recalled product
- Product
- CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- CARBOXYMETHYLCELLULOSE SODIUM
- Manufacturer
- BRS Analytical Services, LLC
- Hazard
- manufacturing-deviation
- sterility-failure
- infection-risk
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 (20)
- Lot
- expiry: Lot 103
- exp 4/26/25
- Lot 104
- exp 5/03/25
- Lot 108
- exp 6/29/25
- Lot 109
- exp 7/18/25
- Lot 110
- exp 8/17/25
- Lot 111
- exp 8/22/25
- Lot 112
- exp 8/27/25
- Lot 113
- exp 9/18/25
- Lot 125
- exp 10/23/25
- Lot 130
Distribution
Distributed nationwide across the United States.
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