Sagent Announces Recall of Metronidazole Injection

Intravenous antimicrobial product recalled due to non-sterility in two lots
By Beth Gilbert
HealthDay Reporter

WEDNESDAY, May 19 (HealthDay News) -- Sagent Pharmaceuticals Inc. has announced a nationwide voluntary recall of all lots of metronidazole injection, USP 500 mg/100 mL, distributed by the company and manufactured by Claris Lifesciences, due to non-sterility in two lots of the product, according to the U.S. Food and Drug Administration (FDA).

Metronidazole injection is an intravenous antimicrobial product used to treat infections. Non-sterility of an intravenously administered antimicrobial agent may lead to infections, which can be fatal, particularly in patients with compromised immune systems. According to the FDA, to date, Sagent knows of no adverse events associated with metronidazole injection.

The lots being recalled were distributed nationwide between February and May 2010 to hospitals, wholesalers and distributors. Adverse events that could possibly be related to the use of the product should be reported to the FDA's Med Watch Program: http://www.fda.gov/Safety/MedWatch/default.htm.

According to a Sagent news release: "Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.SagentPharma.com."

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