FDAFDA · Food and drugs·Recall number D-1038-2013
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
Published September 25, 2013 · Recall initiated: August 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Leiter's Pharmacy
- Distributor
- Nationwide
- Lot
- Lot 06072013@49, Exp 9/5/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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