Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, USP 500 mg/100 mL
ROCKVILLE, Md., May 17, 2010 - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris Lifesciences and distributed by Sagent. 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.
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 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 Food and Drug Administration.
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.com1. Any questions about returning unused product should be directed to the customer call center at (866) 946-4679 M-F 8am-7pm CST. Healthcare workers who have medical questions about metronidazole injection may contact Sagent Medical Affairs (866-625-1618 option 3).
Any adverse events that may be related to the use of this product should be reported to the FDA's Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the Med watch website at www.fda.gov/safety/medwatch/default.htm2.
Ronald Pauli, Sagent,
Tel: (847) 908-1604
Tel: (866) 946-4679
Aline Schimmel, WCG,
Tel: (312) 646-6295
Sagent Medical Affairs
Tel: (866) 625-1618 option 3
Posted: May 2010