Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Not elsewhere classified
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
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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