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news.Sagent Pharmaceuticals has initiated the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg/100ml manufactured by Claris Lifesciences and distributed by Sagent.
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Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container.
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.
Sagent has initiated this voluntary recall to the user level due to the discovery of non-sterility in two lots of metronidazole injection. 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.
Sagent stated that it is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation. This recall is being conducted with the knowledge of the FDA.
Sagent said that customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product.
Sagent said that these lot numbers were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010.