Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of assurance of sterility.
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
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 Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Reason Lack of sterility assurance
Reason Lack of sterility assurance
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
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