Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility

May 17, 2010

Audience: Infectious Disease, Pharmacy

Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL manufactured by Claris Lifesciences and distributed by Sagent 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 is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation.

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, which were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010. Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container.

[05/17/2010 - Press Release - Sagent Pharmaceuticals]

    

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