Eye Lubricant Gel Recalled for Manufacturing Control Failures
AvKARE is recalling carboxymethylcellulose sodium ophthalmic gel due to cGMP deviations and failure to assure sterility. Affected lots were distributed nationwide.
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: This is an FDA Class II recall involving manufacturing control deviations that compromise sterility assurance on an ophthalmic product. No illnesses or injuries have been reported; however, the lack of sterility assurance in an eye lubricant represents a risk of harm to users, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Gel 1%, a sterile eye lubricant gel supplied in 0.5 FL OZ (15 mL) bottles. The product carries NDC 50268-066-15 and was manufactured by BRS Analytical Services, LLC.
The recall was initiated due to cGMP deviations and lack of assurance of sterility. The manufacturing process did not provide adequate controls to ensure the product remains sterile.
Approximately 1,610 cases were affected, with each case containing 24 cartons. The product was distributed nationwide in the USA. The affected lots are: Lot 114 (expiration 9/04/25), Lot 115 (expiration 9/06/25), Lot 116 (expiration 9/10/25), and Lot 207 (expiration 12/05/26).
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
- Hazard
- cgmp-deviation
- sterility-assurance
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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