April 26, 2012
American Regent Recalls Epinephrine Injection, USP, 1:1000, 1mL Ampules Lot #1395
The Missouri Department of Health and Senior Services received the following news release regarding the recall of Epinephrine Injection, USP, 1:1000, 1mL Ampules due to discoloration and small visible particles.
Epinephrine Injection, USP, 1:1000, 1 mL Ampules
Lot #1395, Exp Date: July 2012
Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation.
The product was distributed to wholesalers and distributors nationwide. Hospitals, Retail Pharmacies, Clinics, Physician Offices, and other healthcare facilities and providers should not use American Regent Epinephrine Injection, USP, 1:1000, 1 mL ampules with lot #1395 for patient care and should immediately quarantine any product for return.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm301783.htm?source=govdelivery.