Aug 11, 2017   SOURCE: PR NewsWire

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

SILVER SPRING, Md., Aug. 11, 2017 /PRNewswire/ -- 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:

    --  Complete and submit the report online at
        www.fda.gov/medwatch/report.htm; or
    --  Download and complete the form, then submit it via fax at
        1-800-FDA-0178.

For more information:

Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination

FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections

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.

Media Inquiries: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

View original content with multimedia:http://www.prnewswire.com/news-releases/fda-warns-of-potential-contamination-in-multiple-brands-of-drugs-dietary-supplements-300503420.html

SOURCE U.S. Food and Drug Administration