Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
What was recalled
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
- Recalling firm
- Leiter's Pharmacy
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1038-2013
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.
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