A Texas-based compounding pharmacy is the latest facing a nationwide recall in what is quickly becoming a growing public health concern: tainted medications.
It is alleged that patients have become ill after taking products manufactured at Specialty Compounding, LLC, based in Cedar Park, Texas. Specialty Compounding is in the process of recalling all of the medicines manufactured in that facility dispensed since May 9, 2013 after at least 15 people developed bacterial infections traced back to the medicines.
Patients who received intravenous infusions of calcium gluconate, a drug to treat too much potassium or to correct calcium deficiencies, have reported issues after their treatment at Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional. It is suspected that the medication was not sterile, which caused bloodstream infections; Rhodococcus bacteria was detected, which typically causes symptoms including fever and pain.
The now-recalled batches of calcium gluconate were distributed directly to medical offices and hospitals throughout Texas, and also nationwide to patients, with the exception of North Carolina. Specialty Compounding has announced that is has contacted all customers to notify them of the recall; anyone who is in possession of the product should contact Specialty Compounding at (512) 219-0724 Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT, to find out how to return it.
A spokesperson for Specialty Compounding has announced that the company is voluntarily recalling all sterile products at this time out of concern for patient safety. The Federal Drug Administration inspected the facility in March 2013 and reported “questionable testing practices” and a lack of some procedures to establish drug sterility. Some drug processors were seen wearing improper clothing (i.e., not sterile), according to the findings, and it was noted that there was inadequate drug testing to ensure a lack of unwanted microorganisms.
This April, a new Senate bill was proposed which calls for much tighter regulations for the drug compounding industry. The FDA has called for an increase in its regulatory powers for compounding facilities; the regulatory powers typically fall under state regulations.
In 2012, a compounding facility in Framingham, Mass., The New England Compounding Center, was the center of an investigation after people in 20 states were affected; 750 were sickened, including 63 deaths. Contaminated drugs made at the facility caused an outbreak of fungal infections, including meningitis. More than 17,600 doses of methylprednisolone acetate steroid injections were affected. An investigation by FDA investigators discovered mold and fungal contamination in numerous vials of the drugs, and in areas where the drugs were made.
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