Sagent Pharmaceuticals announced a nationwide voluntary recall of all lots of metronidazole injection, USP 500mg/100mL, an antimicrobial, due to the discovery of non-sterility in two lots. Non-sterility of an antimicrobial administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
The lots of metronidazole injection, USP 500mg/100mL (NDC number 25021-131-82) being recalled were manufactured by Claris Lifesciences and distributed by Sagent from February through May 2010. The lot numbers being recalled are A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm212311.htm.