Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Subpotent Drug: low Anti-Factor IIa potency.
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
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 Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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