Metronidazole Injection Recall Issued Due to Sterility Problems

A nationwide recall has been issued for the antibiotic metronidazole, after several vials of the drug were found to be non-sterile. 

The metronidazole recall was announced on Monday by the FDA and Sagent Pharmaceuticals, Inc., which distributes the antibiotic. The injections are manufactured by Claris Lifesciences.

The recall was issued after two lots of the drugs were found to be non-sterile, which could result in potentially life-threatening infections, especially among people with compromised immune systems. Sagent says that, to date, it has received no reports of infections, injuries or deaths resulting from injection by non-sterile metronidazole.

All lots of metronidazole injection, USP 500mg/100mL, sold in single dose plastic containers, were recalled by Sagent. The intravenous injections were sold to hospitals, wholesalers and distributors nationwide from February through March of this year. The lot numbers included in the recall include A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019.

Sagent has instructed customers to examine their inventory and quarantine any affected lots of the product, discontinue its distribution and return all of it to the company. Anyone who further distributed the vials has been instructed to pass on information regarding the recall to their customers.

Anyone who purchased the vials and have questions can find more information at www.SagentPharma.com. Anyone who has experienced adverse events as a result of being injected with affected lots of metronidazole should report the incident to the FDA’s Med Watch Adverse Events Reporting Program at www.fda.gov/safety/medwatch/default.htm.