The label on the outer package of PRIMAXIN 500 (imipenem and cilastatin sodium) contains incorrect information. The label incorrectly states: “Use reconstituted solution ( 2.5 mg/mL ) within 4 hours if kept at room temperature (15°C – 30°C) or within 24 hours if refrigerated (2°C – 8°C).” (see image below of the incorrect label on the outer package). In fact, when reconstituted and diluted as directed, the final concentration (expressed as imipenem content) will be 5 mg/mL , not 2.5 mg/mL as written above. If the outer package label were relied upon in product administration, this labelling error could possibly result in a patient receiving a double dose of imipenem/cilastatin. The strength of the product (500 mg) as displayed on the outer package, the vial label and the package insert as well as the reconstitution and dilution instructions in the package insert/Canadian Product Monograph are correct.
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