Published On: Wed, Feb 12th, 2014

Gluconate 10% Injections from Rx Formulations Recalled by FDA

The FDA has officially recalled Gluconate 10% Injections from Rx Formulations, a drug compounding pharmacy headquartered in Arizona.  This statement comes after almost three months of investigations into Rx Formulations’ sterility practices.

Global Dispatch 200x119Gluconate 10% Injections are combined with other compounds or drugs to aid in absorption and distribution throughout the body.  Calcium gluconate injections, for example, help prevent necrosis of tissues after deep burns, while quinine gluconate injections have been used to treat malaria.  The compounding procedure performed by Rx Formulations turns gluconic acid into gluconate ions, which are dehydrated into salts that are eventually combined into useful formulations.

Rx Formulations’ Gluconate 10% Injections have been found to be contaminated with an unidentified Gram-positive, rod shaped bacteria.  Members of this bacterial class include dangerous and beneficial species from Bacillus, Listeria, and Clostridium.  The facility initially recalled these injections in mid-November pending FDA safety approval.  On December 26th, Rx Formulations also independently recalled their line of B12 injections due to sterility concerns.  According to their website, one of the safety hoods in which the B12 injections were made had unknowingly malfunctioned, potentially allowing contaminants to mix with their compounds during preparation.  Other products recalled due to the concern with the safety hood include Magnesium Sulfate, Potassium Phosphates 4.4 mEq/ml, Oxytocin 10 Unites/ml, Sodium Bicarbonate 8.4%, and Bupivacaine 3%.

Since the meningitis outbreak of 2012, the FDA has significantly improved its practice of monitoring compounding centers.  Under the new policy, compounding pharmacies can sign up to be regularly inspected by the FDA, which allows them to then be labeled outsourcing facilities, meaning they can sell formulations directly to hospitals and clinics.  The law also gives the FDA license to perform random searches on compounding centers that have not signed up if the FDA deems that facility to be a potential public health risk.  As of this writing, some branches of Rx Formulations had signed up for inspections, but the company as a whole was still unlisted as a registered compounding facility.

A full list of compliant compounding agencies around the US can be found here.

Edward Marks is a PhD student at the University of Delaware.  His research involves the healing of burns and other chronic wounds using nanomedicine techniques, with the goal of pushing any advancement directly into the clinic.  Edward received his BS from Rutgers University and Masters from the University of Delaware.

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