FDA announces Rx Formulation's voluntary recall of sterile drug products
[12/13/2013] The U.S. Food and Drug Administration is alerting 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, Mesa, Ariz. Rx Formulations informed FDA that it is recalling products marketed as sterile that were made in the same area of the facility as the contaminated product.
The following products, compounded in Hood #2 between 11/7/2013 and 12/11/2013, are subject to the recall by Rx Formulations:
- Calcium Gluconate 10%
- Magnesium Sulfate
- Potassium Phosphates 4.4 mEq/ml
- Oxytocin 10 Units/ml
- Sodium Bicarbonate 8.4%
- Bupivacaine 3%
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.
Patients who were administered any sterile product produced by Rx Formulations and have concerns should contact their health care provider.
FDA has not received any adverse event reports associated with calcium gluconate injection from Rx Formulations. FDA asks health care providers and consumers to report adverse reactions or quality problems experienced with products made by Rx Formulations to the FDA's MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178