Carboxymethylcellulose Sodium Ophthalmic Gel recalled for sterility concerns
BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Gel 1% eye lubricant due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility.
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 II recall. The hazard involves lack of assurance of sterility in an ophthalmic (eye) product, which presents significant risk of serious infection if the product is contaminated. Sterile drug products require the highest manufacturing standards, and deviations that undermine sterility assurance in a product applied directly to the eye meet the threshold for Severe classification.
Plain-English summary
BRS Analytical Services, LLC is recalling Carboxymethylcellulose Sodium Ophthalmic Gel 1% (also marketed as Carboxymethylcellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, and Soothing Gel), a sterile ophthalmic gel supplied in 0.5 FL OZ (15 mL) bottles. The product is distributed by AvKARE in Pulaski, Tennessee under NDC 50268-066-15.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility. Affected lots include Lot 114 (exp 9/04/25), Lot 115 (exp 9/06/25), Lot 116 (exp 9/10/25), and Lot 207 (exp 12/05/26). Approximately 1,610 cases (24 cartons per case) have been distributed nationwide in the USA.
Consumers who have purchased this product should stop using it and consult with their eye care professional or pharmacist for guidance on alternative lubricating eye products. Healthcare providers and patients should report any adverse events related to this product to the FDA's MedWatch program or contact BRS Analytical Services, LLC for additional information.
The recalled product
- Product
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
- Manufacturer
- BRS Analytical Services, LLC
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- sterility-assurance
- cGMP-deviation
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 (9)
- Lot
- expiry: Lot 114
- exp 9/04/25
- Lot 115
- exp 9/06/25
- Lot 116
- exp 9/10/25
- Lot 207
- exp 12/05/26
Distribution
Distributed nationwide across the United States.
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