St. Louis, Missouri-based pharmaceutical lab BRS Analytical Services, LLC, has initiated a voluntary recall at the consumer level of five different ophthalmic products due to potential quality concerns.
The move was made by its distributor AvKARE.
First thing’s first: Which products are these?
In its recall notice, BRS identified the following:
- NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
- See here for expiration dates
- NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- See here for expiration dates
- NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
- See here for expiration dates
- NDC# 50268-126-15 Lubricant Eye Drops Solution
- See here for expiration dates
- NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
- See here for expiration dates
In total: This reportedly accounts for nearly 75,000 individual products distributed across the U.S., though specific stores or states were not identified.
And their respective shipment dates?
These range from an initial shipment of May 26, 2023, through April 21, 2025.
Gotcha. Now, backtrack and tell me about this lab and distributor.
BRS Analytical Services is a pharma lab that supplies products to the pharmaceutical industry and provides consulting services within the pharma sector.
- Among these services: Drug development, contract research, dissolution testing, and chromatography
AvKARE, meanwhile, is an FDA-registered and U.S. Drug Enforcement Administration (DEA)-controlled substance distributor of pharmaceuticals and infection control products. Its portfolio: Extends to tablets, capsules, ointments, topical creams, and solutions, to name a few.
- And its vendors include both commercial—retinal chains, independent establishments, hospitals, health systems/networks, long-term care agencies, and educational insitutions—as well as government entities across the country and globe.
Alrighty—back to this recall. What does ‘consumer level’ mean?
This type of recall is considered the most extensive, as it entails the removal of all products from all points in the supply chain—from the manufacturer to, most importantly, consumers.
And what recall FDA classification does this fall under?
That would be Class II, translating to a situation in which the “use of or exposure to a violative product” could potentially cause:
- Temporary or medically irreversible adverse health consequences
- A remote probability of serious adverse health consequences
And what led to its initiation?
Per AvKARE, who reported the recall following notification from BRS, the move was made due to “manufacturing cGMP [Current Good Manufacturing Practice] deviations” uncovered during a recent FDA audit.
A couple of notes:
- cGMP refers to a set of FDA regulations and guidelines enforced by the agency to ensure the overall safety and quality of pharmaceuticals, medical devices, and other federally regulated products distributed across the United States.
- For a deep dive into these, click here.
- “Deviations” refers to any unexpected or unplanned events that diverge (or differ) from approved or standard operating procedures, guidelines, or specifications during the manufacturing, distribution, storage, or testing of pharmaceutical and life sciences products.
Go on …
While deviations are classified into two cateogries—planned and unplanned—it’s the unplanned that can result in a major cause for concern.
These may arise from sources such as:
- Equipment malfunctions resulting in potential contamination or inaccurate test results
- Human errors (miscalculations, mislabeling, or failing to to follow approved procedures)
- Changes in environmental conditions that may impact product stability or sterility
- Issues with raw materials or supply chain
Note: In specific situations involving biological products, the FDA requires manufacturers to report certain “deviations” and unexpected events in manufacturing via a Biological Product Deviation (BPD) report.
And what’s the concern for the deviations in this recall situation?
Keep in mind: The deviations identified in this case were done so by the FDA itself .
While AvKARE noted that the current “health hazard to [users] is unknown,” these cGMP deviations could potentially “lead to products of unacceptable quality.”
- As such: “It is not possible to rule out patient risks resulting from these products,” the distributor stated.
Speaking of risks … any reports of adverse events?
So far? No, AvKARE did not address any specific instances.
And if I need to report an adverse event?
Submit a form online via the FDA’s MedWatch Adverse Event Reporting program or by mail/fax.
What should I do if I have some of these products in my inventory?
Act now: The supplier asks consumers and eyecare providers to immediately discontinue use and remove from active inventory.
For these customers, AvKARE is requesting they complete a Quantity to Return section and a customer information page, accessible here.
- These are to be faxed to 931-292-6229 or emailed to customerservice@avkare.com—even if the quantity is zero.
Will I get a refund?
AvKARE will send a return authorization form for customers to ship back any of their recalled products. See here for where to send them.
Once returned: A full credit will be issued (including shopping costs).