February 10, 2014 — A recall has been issued for calcium gluconate 10% injections and several other medicines compounded by Rx Formulations, due to potential microbial contamination.
The U.S. Food and Drug Administration (FDA) recommends that healthcare professionals should follow up with patients who received the recalled calcium gluconate injections between November 7 and December 11, 2013.
According to the initial FDA warning on December 13, 2013:
“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.”
Patients who receive a contaminated injection medication could develop severe, life-threatening infections. FDA testing confirmed the presence of gram-positive rod bacteria in Lot #778961. Healthcare professionals should immediately check supplies and quarantine the recalled products.
The recall is precautionary, as the FDA has not received any adverse event reports associated with calcium gluconate injections from Rx Formulations.
The following products are subject to 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%
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