FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, FarmaKeio Superior Custom Compounding due to a lack of sterility assurance.
FDA is warning patients and health care professionals not to use products intended to be sterile produced by North American Custom Laboratories LLC, FarmaKeio Superior Custom Compounding due to a lack of sterility assurance.
Quick Take
The FDA has issued a formal warning to healthcare providers and patients to immediately cease the use of all sterile products from North American Custom Laboratories LLC, doing business as FarmaKeio Superior Custom Compounding. The agency cited a significant lack of sterility assurance, which poses a serious risk of infection to patients receiving these compounded medications.
Why It Matters
Compounded ophthalmic medications, such as fortified antibiotics, atropine, or intravitreal injections, require the highest level of sterility to prevent sight-threatening endophthalmitis. When the FDA flags a 'lack of sterility assurance,' it typically indicates that inspectors identified systemic failures in cleanroom protocols, environmental monitoring, or sterilization processes. For eye care providers, this warning necessitates an immediate audit of current inventory to ensure no products from this specific facility are being administered or dispensed.
Key Details
Practice Implications
Clinicians should immediately check office inventory and patient records for any sterile formulations—including eye drops, injections, or pellets—sourced from FarmaKeio Superior Custom Compounding. If a patient has recently received a sterile product from this lab, providers should maintain a high index of suspicion for localized or systemic infection and advise the patient on specific symptoms to monitor.
Who's Affected
What's Next
The FDA will likely continue to monitor the facility's compliance and may provide updates if a formal recall is initiated. Providers should transition to alternative compounding sources that meet 503A or 503B regulatory standards for their sterile medication needs.
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