FDA-Drug2013-07-10Class II

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

Baxter Healthcare Corp.
Hazard

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.

Sold states
Nationwide & Puerto Rico
Affected count
172,296 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-629-2013

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