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FDA Warning: Potential Contamination in Multiple Brands Of Drugs, Dietary Supplements

Author: U.S. Food and Drug Administration(i) : Contact: fda.gov

Published: 2017-08-14 : (Rev. 2020-02-07)

Synopsis:

FDA advises not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination.

Key Points:

Main Digest

Recalled products from Rugby Laboratories, Major Pharmaceuticals, Leader Brands all manufactured by PharmaTech...

The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The drug and dietary supplement products made by PharmaTech include liquid docusate sodium drugs (stool softeners), as well as various dietary supplements including 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 U.S. 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, the FDA advised health care professionals and patients not to use liquid docusate drug products manufactured 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.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drugs and dietary supplements products to the FDA's MedWatch Adverse Event Reporting program:

(i)Source/Reference: U.S. Food and Drug Administration. Disabled World makes no warranties or representations in connection therewith. Content may have been edited for style, clarity or length.

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