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

FDA News Release

• For Immediate Release: August 11, 2017

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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.

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.