Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
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 Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Reason Super Potent and Failed Reconstitution Time
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