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.
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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.