drugs.comAugust 14, 2017
Tag: FDA , Dietary Supplements , liquid drug , PharmaTech LLC of Davie , bacteria Burkholderia cepacia (B. cepacia)
FDA, The U.S. Food and Drug Administration, is suggesting consumers and health care professionals not to use any liquid drug or dietary supplement products produced by Major Pharmaceuticals and Leader Brands, PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, due to underlying contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for serious patient infection. The drug and dietary supplement products made by PharmaTech include stool softeners (liquid docusate sodium drugs), as well as various dietary supplements including liquid vitamin D drops and liquid multivitamins marketed for infants and children.
The drug and dietary supplement products made by PharmaTech include stool softeners, liquid vitamin D drops and liquid multivitamins marketed for infants and children.
"B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems," said FDA Commissioner Scott Gottlieb, M.D. "These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online – making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products."
According to the Centers for Disease Control and Prevention (CDC), B. cepacia poses the greatest threat to hospitalized patients, critically ill patients and people with health problems such as weakened immune systems and chronic lung diseases. The symptoms of B. cepacia infections vary widely from none at all to serious respiratory infections. It can spread from person-to-person by direct contact and is often resistant to common antibiotics.
Consumers, pharmacies and health care facilities should immediately stop using and dispensing all liquid drug and dietary supplement products manufactured by PharmaTech and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands. These distributors voluntarily recalled the following products:
LEADER BRAND
MAJOR PHARMACEUTICALS
RUGBY LABORATORIES
On Aug. 8, 2017, the FDA advised health care professionals and patients not to use any liquid drug products manufactured by PharmaTech, following CDC’s laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia linked to recent patient infections.
In 2016, health care professionals and patients are suggested by FDA not to use liquid docusate drug products produced at PharmaTech’s Davie, Florida, facility after the products were implicated in CDC’s public health investigation into a multistate outbreak of B. cepacia infections.
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