Calcium Gluconate Injection Recall

FOR IMMEDIATE RELEASE - July 18, 2011 - American Regent is conducting a voluntary nationwide recall to the user and consumer level of the following product:

Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package,
Lot # 1006, Expiration Date: January 2013, NDC # 0517-3900-25

PLEASE NOTE: This voluntary nationwide recall, initiated on July 18, 2011 to the user and consumer level is for lot # 1006 only. No other sizes or lots of Calcium Gluconate Injection, USP, are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of this lot may contain silicone particles. 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 due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of product is administered to patients.

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, non-thrombocytopenic 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.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Calcium Gluconate Injection, USP, 10%, Lot # 1006 for patient care, and should immediately quarantine any product for return to American Regent, Inc.

Please Note: Calcium Gluconate Injection, USP, 10% is a supersaturated solution and is prone to precipitation. Other lots and sizes may contain a precipitate that should dissolve upon warming. The Product Package Insert contains directions on dissolving this precipitate should it occur. However, the injection must be clear at the time of use. As stated in the Package Insert: “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

http://www.fda.gov/Safety/Recalls/ucm263531.htm