The FDA advised health care professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, of Mesa, Arizona, between November 7 and December 11, 2013, as a precaution. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations’ calcium gluconate injection product. The testing identified gram-positive rod bacteria in the product, which can cause infection in patients.
The FDA alerted health care providers, hospital supply managers, and pharmacists that 2 to 3 millimeter, irregularly shaped floating matter was observed in calcium gluconate injection from an intact, unused vial produced at Rx Formulations. Rx Formulations informed the FDA that it is recalling products marketed as sterile that were made in the same area of the facility as the contaminated product.
A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection. Therefore, these products should not be administered to patients. Health care providers and hospital staff should immediately check their medical supplies, quarantine the products being recalled, and follow the recall instructions from Rx Formulations.
See the FDA Drug Safety Communication
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication