Vancomycin Injection
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
Compare with the code on your package — it is the most precise check available.
Drug: Vancomycin
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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