Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Subpotent
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
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 CGMP Deviations; particulates identified during visual inspection
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 CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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