Endophth Kit
Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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.
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drug: Ceftazidime
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Lack of assurance of sterility.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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