FDA warns of potential contamination in multiple brands of drugs, dietary supplements by PharmaTech

8/13/2017
U.S. Food and Drug Administration

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 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 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 

Liquid Multivitamin Supplement for Infants and Toddlers 

50 mL 

UPC: 096295128611 

ALL LOTS 

Liquid Vitamin D Supplement for Breastfed Infants 400 IU 

50 mL 

UPC: 096295128628

ALL LOTS  

 

MAJOR PHARMACEUTICALS

Certa-Vite Liquid     

236ML  

00904-5023-09  

ALL LOTS 

Poly-Vita Drops       

50ML    

00904-5099-50   

ALL LOTS 

Poly-Vita Drops W/Iron  

50ML   

00904-5100-50   

ALL LOTS 

Ferrous Drops Iron Supplement 

50ML 

00904-6060-50 

ALL LOTS 

D-Vita Drops              

50ML    

00904-6273-50   

ALL LOTS 

Tri-Vita Drops         

50ML    

00904-6274-50   

ALL LOTS 

Senna Syrup           

237ML 

00904-6289-09   

ALL LOTS       

 

RUGBY LABORATORIES

C Liquid 500mg      

118ML 

00536-0160-97 

ALL LOTS 

Diocto Liquid 50mg/5ml 

473ML  

00536-0590-85

ALL LOTS 

Ferrous Sulfate Elixir   

473ML 

00536-0650-85  

ALL LOTS 

Fer Iron Liquid 50ML     

50ML   

00536-0710-80 

ALL LOTS 

Senexon Liquid             

237ML 

00536-1000-59 

ALL LOTS 

Diocto Syrup 60MG/15ML

473ML 

00536-1001-85 

ALL LOTS 

Aller Chlor Syrup          

120ML  

00536-1025-47 

ALL LOTS 

Calcionate Syrup          

16OZ   

00536-2770-85  

ALL LOTS 

Cerovite Liquid             

236ML  

00536-2790-59 

ALL LOTS 

D3 400iu Liquid             

50ML   

00536-8400-80  

ALL LOTS 

Poly-Vitamin Liquid  

50ML    

00536-8450-80 

ALL LOTS 

Tri-Vitamin Liquid      

50ML   

00536-8501-80  

ALL LOTS 

Poly-Vitamin W/Iron Liquid 

50ML  

00536-8530-80 

ALL LOTS

 

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:


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.

View Count 321
Lamsari