Sterile medical devices and products should be free from any life form, such as bacteria or viruses. Sometimes, that is not the case and adverse reactions occur from non-sterile medical products. For instance, a few months ago The Food & Drug Administration discovered gram-negative bacteria in a chromium chloride injection, prompting the manufacturer, Balanced Solutions, to recall all of its non-expired sterile products. Similarly, this week Specialty Compounding is recalling all lots of sterile medications due to reports of bacterial infections.
According to a press release, the recall was prompted by reports of bacterial infections in 15 patients in Corpus Christi, Texas. The patients had received IV infusions of calcium gluconate at two hospitals. In the press release, Specialty Compounds states that “there is a potential association between the infections and the medication at this time.” According to USA Today, the infusions can be used as part of the treatment of cardiac arrest. Additionally, calcium deficiency and extremely high potassium levels can be treated with the infusions.
When products that are meant to be sterile contain microbial contamination, patients can develop serious infections that can be life threatening. Since last September’s outbreak of fungal meningitis, the FDA has increased inspections and the media and public have placed increased scrutiny on pharmaceutical companies. 63 people died and 749 people developed an illness due to last year’s outbreak, which was “caused by steroid injections from the New England Compounding Center in Massachusetts.”
Specialty Compounding’s recall applies to all unexpired sterile compounded units that were distributed since May 9. The recall includes all strengths and dosage forms of the units. The products were distributed at hospitals and physician offices in Texas, and were also sent to patients’ homes in all states except North Carolina.
The company is informing consumers about the recall via phone, email, fax and/or regular mail. Specialty Compounding urges people who use or have received any affected products to immediately discontinue the use of the products and return them to the company. Consumers can contact Specialty Compounding at 512-219-0724 weekdays from 10 a.m. to 5 p.m. CDT.