The FDA is alerting health-care providers, hospital supply managers and pharmacists that 2- to 3-mL, irregularly shaped floating matter was observed in an intact, unused vial of calcium gluconate injection produced at Rx Formulations, in Mesa, Ariz.
Rx Formulations informed the agency that it is recalling products marketed as sterile that were made in the same area of the facility as the contaminated product:
• 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,” the FDA noted. “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.”
Futher, “patients who were administered any sterile product produced by Rx Formulations and who have concerns should contact their health care provider.”
The FDA stressed that it has not yet received any adverse event reports associated with calcium gluconate injection from Rx Formulations. Any ill effects or quality issues associated with products made by the company should be reported to the FDA’s MedWatch Adverse Event Reporting program, the agency noted.
Reports can be completed and submitted online at www.fda.gov/medwatch/report.htm. A form can also be downloaded at http://1.usa.gov/1iwTlsT
, filled out and faxed to the FDA at 1-800-FDA-0178.