Home / Recalls / Leiter's Pharmacy / D-1038-2013

D-1038-2013 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
56 vials

Product Description

Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, 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 results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Distribution Pattern

Nationwide

Code Information

Lot 06072013@49, Exp 9/5/13

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-1040-2013 Class II — Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leite (August 26, 2013)