FDA News

B. cepacia infections prompt FDA warning on liquid products

The FDA is warning health care providers and others not to use any liquid product manufactured by Davie, Florida-based PharmaTech following recently reported Burkholderia cepacia infections.

CDC testing found a B. cepacia strain linked to patient infections in oral liquid docusate manufactured by the company, according to an FDA MedWatch safety report. Citing the ongoing investigation, FDA spokeswoman Lauren Smith Dyer declined to say how many patients had confirmed infections and how widespread the impact could be.

“We will provide additional information when we are able to do so,” she told Infectious Disease News. “Most importantly, we urge health care professionals to carefully check their supply and not use any liquid product manufactured by PharmaTech. We also encourage patients who have concerns to contact their health care professionals.”

Infectious Disease News was unable to contact PharmaTech officials for comment.

A distributor of PharmaTech docusate, Livonia, Michigan-based Rugby Laboratories, issued a voluntary recall of two products — Diocto Liquid and Diocto Syrup — on Aug. 3. A MedWatch report at the time attributed the recall to “a risk of product contamination with B. cepacia.”

The distributor issued the recall after receiving reports of  “several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech-manufactured Diocto Syrup or Diocto Liquid,” a Rugby statement read.

After receiving more information from the FDA, the statement continued, Rugby and two other companies distributing PharmaTech products — Leader Brand and Major Pharmaceuticals — recalled all PharmaTech liquid products as a precaution. A subsequent FDA statement said the recalled products had been distributed nationwide.

According to the CDC, B. cepacia poses the greatest threat to patients who are hospitalized or critically ill patients and people with a history of health problems such as weakened immune systems and chronic lung diseases. Symptoms of B. cepacia infection range from no outward signs to serious respiratory infections. Infections are transmissible by person-to-person by direct contact and are often resistant to common antibiotics.

Anyone with questions regarding the recall can contact Rugby Laboratories and Major Pharmaceuticals customer support at 1-800-645-2158, Monday through Friday from 8 a.m. to 8 p.m., Eastern Standard Time or Leader customer support at 1-800-200-6313, option 1, Monday through Thursday from 8 a.m. to 7 p.m. and Friday from 8 a.m. to 5 p.m.

The FDA warned that various PharmaTech liquid products could be tainted.

“Such products might have been labeled and distributed by Rugby and other companies,” the agency’s release stated. “Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator.”

The FDA release went on to say that the products in question do not bear a PharmaTech label.

“The FDA advises health care facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, to check with their suppliers to determine the identity of the manufacturer,” it read.

Health care providers and patients can report adverse events or side effects to the FDA MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report. They can also call 1-800-332-1088 to request a reporting form, which they can complete and mail back or fax to 1-800-FDA-0178.

PharmaTech’s Diocto brand docusate was linked to a 2016 B. cepacia outbreak in which at least 60 people in eight states were infected. The company issued a voluntary nationwide recall of the product, which also was distributed by Rugby Laboratories. – by Joe Green

The FDA is warning health care providers and others not to use any liquid product manufactured by Davie, Florida-based PharmaTech following recently reported Burkholderia cepacia infections.

CDC testing found a B. cepacia strain linked to patient infections in oral liquid docusate manufactured by the company, according to an FDA MedWatch safety report. Citing the ongoing investigation, FDA spokeswoman Lauren Smith Dyer declined to say how many patients had confirmed infections and how widespread the impact could be.

“We will provide additional information when we are able to do so,” she told Infectious Disease News. “Most importantly, we urge health care professionals to carefully check their supply and not use any liquid product manufactured by PharmaTech. We also encourage patients who have concerns to contact their health care professionals.”

Infectious Disease News was unable to contact PharmaTech officials for comment.

A distributor of PharmaTech docusate, Livonia, Michigan-based Rugby Laboratories, issued a voluntary recall of two products — Diocto Liquid and Diocto Syrup — on Aug. 3. A MedWatch report at the time attributed the recall to “a risk of product contamination with B. cepacia.”

The distributor issued the recall after receiving reports of  “several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech-manufactured Diocto Syrup or Diocto Liquid,” a Rugby statement read.

After receiving more information from the FDA, the statement continued, Rugby and two other companies distributing PharmaTech products — Leader Brand and Major Pharmaceuticals — recalled all PharmaTech liquid products as a precaution. A subsequent FDA statement said the recalled products had been distributed nationwide.

According to the CDC, B. cepacia poses the greatest threat to patients who are hospitalized or critically ill patients and people with a history of health problems such as weakened immune systems and chronic lung diseases. Symptoms of B. cepacia infection range from no outward signs to serious respiratory infections. Infections are transmissible by person-to-person by direct contact and are often resistant to common antibiotics.

Anyone with questions regarding the recall can contact Rugby Laboratories and Major Pharmaceuticals customer support at 1-800-645-2158, Monday through Friday from 8 a.m. to 8 p.m., Eastern Standard Time or Leader customer support at 1-800-200-6313, option 1, Monday through Thursday from 8 a.m. to 7 p.m. and Friday from 8 a.m. to 5 p.m.

The FDA warned that various PharmaTech liquid products could be tainted.

“Such products might have been labeled and distributed by Rugby and other companies,” the agency’s release stated. “Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator.”

The FDA release went on to say that the products in question do not bear a PharmaTech label.

“The FDA advises health care facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, to check with their suppliers to determine the identity of the manufacturer,” it read.

Health care providers and patients can report adverse events or side effects to the FDA MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report. They can also call 1-800-332-1088 to request a reporting form, which they can complete and mail back or fax to 1-800-FDA-0178.

PharmaTech’s Diocto brand docusate was linked to a 2016 B. cepacia outbreak in which at least 60 people in eight states were infected. The company issued a voluntary nationwide recall of the product, which also was distributed by Rugby Laboratories. – by Joe Green