American Regent has recalled a batch of calcium gluconate injections because they were found to contain silicone particles.
Injection of particles can result in disruption of blood flow within the small blood vessels of the lungs, localized inflammation (swelling and redness) and granuloma formation.
A granuloma is a benign growth caused by a mass of immune cells. These cells attempt to seal off the offending foreign particles in the body because the immune system cannot eliminate them and this then results in a granuloma.
Calcium gluconate injections are used to treat calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy.
It can also be used to treat muscle cramping, rickets and black widow spider bites, in addition to itchy rashes caused by drugs and a variety of allergic skin conditions.
The affected lot number is 1006 with an expiration date of January 2013, NDC 0517-3900-25.
Medical professionals should not use this injection and should immediately return it to American Regent.
Any doctor with questions regarding the recall can contact the Professional Services Department on 1-877-788-3232, Monday through Friday, 9am-5pm, EDT.
Adverse reactions can be reported to American Regent via email at: [email protected]
They can also be reported to the FDA online at:
www.fda.gov/medwatch/report.htm
Sources:
FDA Press Release, 18th July 2011 - http://www.fda.gov/Safety/Recalls/ucm263531.htm
Granuloma: What does it Mean? Mayo Clinic - http://www.mayoclinic.com/health/granuloma/AN00830
Reviewed July 21, 2011
by Michele Blacksberg R.N.
Edited by Jody Smith