Hospira announced a nationwide voluntary recall of one lot of Labetalol Hydrochloride Injection, USP, 100mg/20mL (5mg/mL), 20mL Multidose Vials due to visible particles embedded in the glass as well as the presence of visible particles floating in the solution following a customer complaint. Labetalol Hydrochloride Injection, USP is indicated for treatment of severe hypertension in adults ≥18 years of age.
The affected vials are from Lot 36-225-DD (NDC 0409-2267-20, Exp date 12/1/2015), and was distributed nationwide in February 2014 to wholesalers/distributors, hospitals, and clinics. If the particulate is undetected in solution and is administered, it may potentially block the administration of the solution to the patient, resulting in a delay of therapy. Smaller pieces of the particulate may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. Although the occurrence is rare, if the particulate is exposed to strong magnetic fields (eg, MRI), it could potentially dislodge and cause tissue damage.
Hospira advises consumers to immediately stop using any affected products. It will be notifying its direct distributors/customers via a recall letter and will arrange for return/replacement of all recalled product.
For more information call (800) 386-2076 or visit FDA.gov.