The Food and Drug Administration (FDA) is urging health care professionals to follow up with patients treated with injections of calcium gluconate 10% made by Rx Formulations between Nov. 7 and Dec. 11, 2013. Testing on the product has confirmed the presence of microbial contamination, specifically gram-positive rod bacteria, which could cause adverse health consequences and possibly serious infection.
Calcium gluconate is used to treat calcium deficiency and postmenopausal osteoporosis. It also treats black widow spider bites, lead colic, overdose of magnesium or certain heart medicines, and a condition called rickets. It is also used in life support and life-threatening heart conditions.
The FDA has not received any reports of adverse events associated with calcium gluconate 10 % made by Rx Formulations. Patients who administered any drugs marked as sterile produced by Rx Formulations between Nov. 7 and Dec. 11, 2013, who have concerns should contact their health care provider.
Any side effects associated with this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.