Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
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 Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason Failed pH Specifications
Reason Lack of sterility assurance
Reason Lack of assurance of sterility.
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