Federal drug regulators are asking doctors to follow up with any patients who received calcium gluconate injections from Rx Formulations, because shots received from the compounding pharmacy may have been contaminated.
On February 6, the FDA announced that testing has confirmed microbial contamination of at least one lot of Rx Formulations calcium gluconate 10% injections. The agency says that doctors should follow up with patients who received injections from the Arizona-based compounding pharmacy as a precaution.
In December, all of Rx Formulation’s sterile products were recalled after floating matter was observed in an unused, intact vial of calcium gluconate 10% from lot #778961 produced by Rx Formulations in Mesa, Arizona. Testing has now confirmed that it was microbial contamination.
Several other products were also recalled that were made in the same area of the facility and were supposed to be sterile, including magnesium sulfate, potassium phosphates 4.4 mEq/ml, oxytocin 10 Units/ml, sodium bicarbonate 8.4%, and bupivacaine 3%.
The FDA warns that contaminated shots could lead to adverse health consequences and possibly a serious infection. However, there have been no adverse events associated with the recalled compounded drugs to date.
The recall comes in the wake of a nationwide fungal meningitis outbreak that was tracked back to epidural steroid injections distributed by the now-defunct compounding pharmacy, New England Compounding Center (NECC). The outbreak lasted nearly a year, sickened more than 700 people and killed more than 60.
Like the recalled calcium gluconate injections, FDA investigators found visible contaminants floating in supposedly sterile injections.
The outbreak led to new compounding pharmacy rules, and fungal meningitis lawsuits pushed NECC into bankruptcy.
NECC has agreed to the creation of a $100 million settlement fund for victims and their families, and lawsuits are still pending against pain clinics and hospitals which distributed the contaminated shots.