Leiter's Pharmacy recalls Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Phar
Recalled September 25, 2013 · FDA recall D-1039-2013 · 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. · FDA Class II
Units
810 vials
Sold at
Nationwide
Description
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.
Product
Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Manufacturer(s)
Leiter's Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →