FDA Warns of Potential B. cepacia Contamination in Drugs, Dietary Supplements

The Food and Drug Administration (FDA) is advising consumers and healthcare professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Fla., 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, MD. “These products were distributed nationwide to retailers, healthcare 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 healthcare 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 healthcare 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 healthcare 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

Source: FDA