drugs Class II Updated 2013-07-10

Baxter Healthcare Corp. recalls Heparin Sodium and 0.9% Sodium Chloride Injection, a) Produc

Recalled Product

Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015


Hazard / Issue

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
View official government recall

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