Justin Cooper , 2025-05-13 19:56:00
Key takeaways:
- BRS Analytical Services initiated a voluntary recall of five ophthalmic products.
- Consumers should stop using these products.
Editor’s note: This is a developing news story. Please check back soon for updates.
An artificial tear solution is one of five ophthalmic products now under recall due to lapses in manufacturing processes, according to the FDA.
An artificial tear solution is one of five ophthalmic products now under recall due to lapses in their manufacturing processes. Image: Adobe Stock
The voluntary recalls were initiated by BRS Analytical Services following an FDA audit that revealed deviations from the agency’s current good manufacturing practice regulations and a “lack of assurance of sterility.” The products were supplied by the medical distributor AvKARE.
Any health hazards resulting from these issues are not currently known, according to an announcement from AvKARE. The FDA designated the recalls as class II, indicating potential “temporary or medically reversible adverse health consequences.”
The recalled products are:
- 13,872 cases of artificial tears ophthalmic solution (NDC 50268-043-15);
- 1,610 cases of carboxymethylcellulose sodium ophthalmic gel 1% (NDC 50268-066-15);
- 32,876 cases of carboxymethylcellulose sodium ophthalmic solution (NDC 50268-068-15);
- 13,104 cases of lubricant eye drops solution (NDC 50268-126-15); and
- 14,333 cases of polyvinyl alcohol ophthalmic solution (NDC 50268-678-15).
The recalled products were shipped between May 26, 2023, and April 21, 2025, and should no longer be used. Consumers who have these products can complete AvKARE’s recall form and return it to the company by fax or email. The products can then be mailed back to AvKARE.
BRS Analytical Services is an independent contract testing laboratory based in St. Louis, according to an archived version of its website. The website no longer exists at the time of publication.
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