FDAFDA · Food and drugs·Recall number D-1040-2013
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
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/failed results were reported to customers as passing. Hence the sterility of the 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 #: 08052013@1, 08052013@4, Exp 11/03/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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