AUDIENCE: Health Professional, Risk Manager, Patient
ISSUE: FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013. 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. A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection.
BACKGROUND: Rx Formulations recalled products marketed as sterile on December 13, 2013.
RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, and quarantine the affected products.
Patients who were administered any drug marketed as sterile produced by Rx Formulations between Nov. 7 and Dec. 11, 2013, and who have concerns, should contact their health care provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[02/06/2014 - FDA Drug Safety Statement - FDA]