Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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