Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations; particulates identified during visual inspection
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
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; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20…
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason Lack of sterility assurance
Reason Subpotent
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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