July 19, 2011
RECALL: American Regent Recalls Calcium Gluconate Injection 10%American Regent is conducting a voluntary nationwide recall of one lot of calcium gluconate injection 10% because some of the vials may contain silicone particles. Potential adverse events after IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation, and granuloma formation. The recalled Lot #1006 is supplied as a 100mL Pharmacy Bulk Package, NDC #0517-3900-25, exp. January 2013.
Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage. Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy.
Healthcare facilities and patients who have the recalled product in their possession should stop using it immediately.
For more information call (877) 788-3232 or visit www.americanregent.com.