IGMPI India

Hospira Inc. has issued a nationwide voluntary recall of one lot of Labetalol hydrochloride injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, with expiration date of 12/01/2015. The NDC and lot number can be found on the right-hand side of the primary label. The recall is at user level.

The recall was initiated due to a confirmed customer report of embedded particulate within the glass vial and visible particles floating in the solution. The embedded particle was identified as stainless steel and the floating particulate as iron oxide. The company is working with its suppliers on implementing corrective and preventive actions.

The presence of particulate may lead to health problems depending upon the amount of particulate matter injected into the patient, the size of the particles the patient's underlying medical condition and heart abnormalities. Blocked administration of the drug to the patient can also cause delay in the therapy. Labetalol hydrochloride injection, USP is a clear colorless solution for intravenous administration and is indicated for control of blood pressure in severe hypertension. The injection is packaged in a 20 ml multidose glass vial, each vial is packaged within an individual carton, and 50 individual cartons are packaged within each shipping container. The recalled lot was distributed nationwide in the U.S. in February, 2014, to wholesalers/distributors, hospitals and clinics.

Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. The company is notifying its distributors and customers by issuing a recall notification letter and will arrange for return/replacement of all recalled products. The recall is being conducted with the knowledge of US FDA.