Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70
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…
Reason Lack of assurance of sterility.
Reason Lack of sterility assurance
Reason Lack of sterility assurance
Reason cGMP deviations: Temperature abuse
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