FDAFDA · Food and drugs·Recall number D-629-2013
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Published July 10, 2013 · Recall initiated: May 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METRONIDAZOLE
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Nationwide & Puerto Rico
- Lot
- Lot #: P280123, P280123A, Exp 2/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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