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 โ€“ 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 LOTSย 

MAJOR PHARMACEUTICALS

Certa-Vite Liquidย ย ย ย ย 

236MLย 

00904-5023-09ย ย 

ALL LOTS

Poly-Vita Dropsย ย ย ย ย ย ย 

50MLย ย ย 

00904-5099-50ย ย 

ALL LOTS

Poly-Vita Drops W/Ironย 

50MLย ย ย 

00904-5100-50ย ย 

ALL LOTS

Ferrous Drops Iron Supplement

50MLย 

00904-6060-50ย 

ALL LOTS

D-Vita Dropsย ย ย ย ย ย ย ย ย ย ย ย ย ย 

50MLย ย ย 

00904-6273-50ย ย 

ALL LOTS

Tri-Vita Drops ย ย ย ย ย ย ย ย 

50MLย ย ย 

00904-6274-50ย ย 

ALL LOTS

Senna Syrupย ย ย ย ย ย ย ย ย ย ย 

237MLย 

00904-6289-09ย ย 

ALL LOTSย ย ย ย ย ย 

RUGBY LABORATORIES

C Liquid 500mgย ย ย ย ย ย 

118MLย 

00536-0160-97ย 

ALL LOTS

Diocto Liquid 50mg/5ml

473MLย 

00536-0590-85

ALL LOTS

Ferrous Sulfate Elixirย ย ย 

473MLย 

00536-0650-85ย ย 

ALL LOTS

Fer Iron Liquid 50MLย ย ย ย ย 

50MLย ย ย 

00536-0710-80ย 

ALL LOTS

Senexon Liquidย ย ย ย ย ย ย ย ย ย ย ย 

237MLย 

00536-1000-59ย 

ALL LOTS

Diocto Syrup 60MG/15ML

473MLย 

00536-1001-85ย 

ALL LOTS

Aller Chlor Syrupย ย ย ย ย ย ย ย ย ย 

120MLย 

00536-1025-47ย 

ALL LOTS

Calcionate Syrupย ย ย ย ย ย ย ย ย ย 

16OZย ย ย 

00536-2770-85ย ย 

ALL LOTS

Cerovite Liquidย ย ย ย ย ย ย ย ย ย ย ย ย 

236MLย 

00536-2790-59ย 

ALL LOTS

D3 400iu Liquid ย ย ย ย ย ย ย ย ย ย ย 

50MLย ย ย 

00536-8400-80ย ย 

ALL LOTS

Poly-Vitamin Liquidย ย 

50MLย ย ย 

00536-8450-80ย 

ALL LOTS

Tri-Vitamin Liquidย ย ย ย ย ย 

50MLย ย ย 

00536-8501-80ย ย 

ALL LOTS

Poly-Vitamin W/Iron Liquidย 

50MLย ย 

00536-8530-80ย 

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:

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, [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

RELATED LINKS
http://www.fda.gov

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Fidoc
August 16, 2017 1:28 am

Hi,
Thanks for sharing really helpful and information with us.

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