On Friday, FDA issued an advisory recommending consumers and health care professionals not use any liquid drugs or dietary supplements manufactured by a Florida-based company and labeled by three distributors due to potential contamination from a bacteria and the risk for severe patient infection.
The products subject to the advisory are potentially contaminated with the bacteria Burkholderia cepacia (B. cepacia), the agency said.
FDA advised consumers, pharmacies and health care facilities to immediately stop using and dispensing the liquid drug and dietary supplement products, which are manufactured by PharmaTech LLC and labeled by Leader Brands, Major Pharmaceuticals and Rugby Laboratories.
The dietary supplements include liquid vitamin D drops and liquid multivitamins marketed for children and infants, the agency said.
On Aug. 8, 2017, FDA advised health care professionals and patients not to use any liquid drug products manufactured by PharmaTech following laboratory testing by the Centers for Disease Control and Prevention (CDC). In testing PharmaTech’s oral liquid docusate, CDC identified a strain of B. cepacia linked to recent patient infections, FDA noted.
“B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems," FDA Commissioner Scott Gottlieb, M.D., said in a statement. “These products were distributed nationwide to retailers, health care facilities, pharmacies and sold onlinemaking it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products."
Citing CDC, FDA reported the bacteria poses the greatest threat to patients who are hospitalized and critically ill, as well as individuals who suffer from such health ailments as a chronic lung disease or compromised immune system.
FDA noted the bacteria can spread to individuals through direct contact and is frequently resistant to common antibiotics.
INSIDER was unable to find current contact information for PharmaTech LLC, and a number listed online for the company was disconnected.
However, the distributors issued a nationwide voluntary recall of several lots of liquid products possibly subject to the contamination and manufactured by PharmaTech.
The affected products were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies, according to a recall announcement by Leader Brands, Major Pharmaceuticals and Rugby Laboratories.
“The distribution firms are committed to patient safety and are partnering with the Food and Drug Administration to notify customers who may be in possession of liquid products manufactured by PharmaTech LLC," the companies said.
Corey Kerr, a media representative listed for Rugby Laboratories and Major Pharmaceuticals, said via email she had no additional comment beyond the statements in the recall announcement.
In July 2016, FDA advised health care professionals that PharmaTech was voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories of Livonia, Michigan.
FDA said it confirmed the product has been contaminated with B. cepacia linked to an outbreak in five states. As of August 2016, CDC had confirmed 60 cases from eight states.
At the time, FDA reminded manufacturers of liquid products such as docusate sodium that it was important to have in place strong manufacturing and testing to confirm low levels of microorganisms and the absence of those that may cause infection.
FDA reported its investigation associated with the 2016 multistate outbreak identified the bacteria “in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment." FDA also revealed its probe identified B. cepacia in the water system used to make the product.
Multiple companies, including Rugby Laboratories, distributed and labeled the liquid docusate drug products, according to the public health agency.
FDA disclosed it has received reports in 2017 of multiple adverse events related to oral liquid docusate sodium products. The agency encouraged health care professionals and patients to report such adverse events to its MedWatch Adverse Event Reporting program.