Home / Recalls / Leiter's Pharmacy / D-1040-2013

D-1040-2013 Class II Terminated

Recalled by Leiter's Pharmacy — San Jose, CA

Recall Details

Product Type
Drugs
Report Date
September 25, 2013
Initiation Date
August 26, 2013
Termination Date
August 14, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
265 vials

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Lot #: 08052013@1, 08052013@4, Exp 11/03/2013

Other recalls by Leiter's Pharmacy

  • D-1041-2013 Class II — Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compo (August 26, 2013)
  • D-1039-2013 Class II — Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, (August 26, 2013)
  • D-1038-2013 Class II — Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, (August 26, 2013)