Imipenem and Cilastatin Injection 500 mg/500 mg single-dose vials have a labelling text error on the outer side panel of the multi-vial carton. It indicates that the reconstituted product contains 2.5 mg/mL of imipenem and cilastatin (see image below of the incorrect side panel of the carton). In fact, the correct concentration after reconstitution and dilution is 5 mg/mL. This labelling error could possibly result in a patient receiving a double dose of imipenem/cilastatin. The strength of the product displayed on the front panel of the carton, the vial label and the package insert as well as the reconstitution and dilution instructions in the package insert are correct.
RecallTracker