Another Dangerous Drug Recall from a Compounding Pharmacy Issued After 15 Infections Reported
After last fall’s fungal meningitis dangerous drug recall, another compounding pharmacy, this time in Texas, has reported a series of infections related to its products and has issued a recall.
Specialty Compounding, LLC, of Cedar Park, Texas, has issued a dangerous drug recall for all lots of its unexpired sterile medications dispensed since May 9, 2013, in all strengths and doses.
The dangerous drug recall was issued after two Texas hospitals reported that 15 people had developed bacterial infections after being treated with the compounding pharmacy’s medications. The patients received intravenous (IV) infusions of calcium gluconate, a drug used to treat calcium deficiencies and patients that have too much potassium in their blood.
The 15 patients came down with a blood infection from Rhodococcus bacteria, which can cause symptoms like fever and pain.
“Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution,” Ray Solano, RPh, pharmacist in charge at Specialty Compounding, said in a statement posted regarding the dangerous drug recall the FDA’s website. “We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern.”
In March, FDA investigators inspecting the Texas-based compounding pharmacy found questionable testing practices, as well as lack of procedures to establish drug sterility.
Although the fungal meningitis outbreak last year prompted the FDA to crack down on state agencies and their inconsistent regulations of compounding pharmacies, this latest dangerous drug recall illustrates the difficulty local and state governments have in defining what compounding pharmacies do, and regulating their products.
The FDA said that it is working with the CDC as well as Texas state officials to determine how widespread the contamination is. While both the compounding pharmacy and infected patients are in Texas, Specialty Compounding’s drugs have been distributed nationwide.
Specialty Compounding said they will notify customers by telephone, fax, email, and/or regular mail regarding the dangerous drug recall. To return product or request assistance related to this recall, users should contact Specialty Compounding at 512-219-0724, Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT.
The Strom Law Firm Can Help with Personal Injury Claims from Dangerous Drug Recalls
If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, you may be entitled to file a personal injury lawsuit. Defective medical devices and dangerous drugs can hurt you to such a great extent that you are unable to work. You will face mounting medical bills as you seek treatment for another’s mistake. The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800