Enforcement Report: Hospira Inc. Lack of Assurance of Sterility and Presence of Particulate Matter

Drugs	Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02	Lot 25-097-DK; Exp 01/01/2015	Class II	Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.	Hospira Inc.
Biologics	Tendon	2643580002008; 2643590002008; 2643600002008; 2643610002008; 2643620002008; 2643630002008; 2643640002008; 2643650002008; 2643660002008; 2643670002008;	Class II	Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed.	University Of Miami Miller School of Medicine Tissue Bank
Drugs	0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09	Lot 34-609-FW; Exp 10/15	Class II	Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.	Hospira Inc.