FDA-Drug2013-09-25Class II

Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, 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 the products cannot be assured.

Sold states
Nationwide
Affected count
265 vials
Manufactured in
1700 Park Ave, N/A, San Jose, CA, United States
Products
Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, 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-1040-2013

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