Metronidazole Injection Recalled for Sterility Issues

Sagent Pharmaceuticals, Inc. just announced the voluntary nationwide recall of all lots of <"">metronidazole injection, the U.S. Food and Drug Administration (FDA) just announced. The injections—USP 500mg /100mL—which were manufactured by Claris Lifesciences and distributed by Sagent.

The metronidazole injections are being recalled due to the discovery of non-sterility in two lots of the injection. Non-sterility of an antimicrobial such as metronidazole injections, which are administered intravenously, has the potential to result in infections. These infections 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
• A000019

The recalled metronidazole injections 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.

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