Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sodium Citrate 4% containing Gentamicin 320 mcg/mL Recalled by JCB Labs LLC Due to Lack of Assurance of Sterility: The product lots...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact JCB Labs LLC directly.
Affected Products
Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
Quantity: 397 vials
Why Was This Recalled?
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About JCB Labs LLC
JCB Labs LLC has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report