The FDA is advising healthcare professionals to follow-up with patients who received calcium gluconate 10% injections produced by Rx Formulations between November 7 and December 11, 2013. The company recalled the product marketed as sterile on December 13, 2013 due to the identification of gram-positive rod bacteria with microbial contamination in lot #778961. Calcium gluconate is used in the treatment of hypocalcemia.
Healthcare providers and hospital staff are being warned to investigate their medical supplies immediately and quarantine any affected products. Patients that received a drug produced by Rx Formulations that was marketed as sterile between November 7 and December 11, 2013 should contact their health care provider if they have questions or concerns.
For more information call (818) 344-3344 or visit the FDA Safety Alert page.