FDA-Drug2013-09-25Class II
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
Leiter's Pharmacy
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.
Sold states
Nationwide
Affected count
56 vials
Manufactured in
1700 Park Ave, N/A, San Jose, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2013Don't want to check this manually?
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