Drug recall D-629-2013

Class II Terminated reported Jul 10, 2013

Product

Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48

Reason for recall

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.

Lots and codes

Lot #: P280123, P280123A, Exp 2/14

Recall details

Recalling firm
Baxter Healthcare Corp., Deerfield, IL
Quantity
172,296 units
Distribution
Nationwide & Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
May 21, 2013
Terminated
June 18, 2015

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