FDA-Drug2013-09-25Class II
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, 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/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Sold states
Nationwide
Affected count
728 vials
Manufactured in
1700 Park Ave, N/A, San Jose, CA, United States
Products
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, 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-1041-2013Don't want to check this manually?
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