Non-sterile metronidazole USP injections recalled
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Sagent Pharmaceuticals issued a nationwide voluntary recall Monday of all lots of metronidazole injection, USP 500 mg/100 mL, because of non-sterile products discovered in two lots, according to a press release.
USP is an IV antimicrobial used to treat infections and is supplied in a single-dose plastic container. Non-sterility of an antimicrobial administered via IV has the potential to result in potentially fatal infections, particularly among patients who are immunocompromised, the FDA said in a MedWatch safety statement.
Recalled lot numbers were distributed to hospitals, wholesalers and distributors from February through May and include: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019.
Sagent is not aware of any adverse events related to the recalled product thus far and will continue to investigate, according to the FDA.