The U.S. Food and Drug Administration is advising healthcare professionals and patients not to use liquid products manufactured by PharmaTech because they may be contaminated with a bacteria that can cause severe infections.
Those infections include pneumonia. Lymphoma patients can develop pneumonia due to a weakened immune system, so they should be among those avoiding PharmaTech liquid products.
A number of people have reported adverse events with constipation medicines known as oral liquid docusate sodium products during 2017. The bacteria involved is Burkholderia cepacia, or B. cepacia.
“Patients, pharmacies, and healthcare facilities that have the recalled product on hand should stop using and dispensing them immediately,” the FDA said. “Patients who are using liquid drug products and who have concerns should contact their healthcare professional.”
B. cepacia can cause pneumonia in people with a lung disease and a suppressed immune system.
Many consumers will have trouble identifying PharmaTech products because they don’t display the company’s label. Instead, they contain the labels of distributors such as Leader Brand, Major Pharmaceuticals, and Rugby Laboratories.
Rugby Laboratories began recalling two PharmaTech oral liquid docusate products on Aug. 3: Diocto Liquid and Diocto Syrup.
A Centers for Disease Control and Prevention investigation of a 2016 outbreak of B. cepacia traced it to oral liquid docusate sodium manufactured by PharmaTech. A number of the infections required intensive medical care.
Investigators also detected B. cepacia in the water system used to manufacture the product.
At the time, the FDA advised healthcare professionals and patients not to use liquid docusate products made at PharmaTech’s Davie, Florida, facility.
PharmaTech’s liquid products, including drugs and dietary supplements used in infants and children, are distributed nationwide. You can consult the FDA recall announcement for a list of recalled products with photos.
Healthcare professionals and patients are encouraged to report adverse events or quality problems with liquid docusate sodium products to the FDA’s MedWatch Adverse Event Reporting program. You can fill out and submit a reporting form online at www.fda.gov/medwatch/report.htm. Or you can download a form, complete it, and fax it to 1-800-FDA-0178.
