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FDA updates on 2017 Burkholderia cepacia contamination

FDA lab findings again link Rugby Diocto oral liquid docusate sodium to B. cepacia infections

Update [10/27/2017] FDA testing has identified Burkholderia cepacia in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech LLC, Davie, Florida. This lot was collected by FDA in response to a 2017 multistate outbreak of B. cepacia complex (BCC) bacterial infections that has affected at least eight patients in California and Maryland. Laboratory evidence from FDA and CDC indicates that PharmaTech’s docusate sodium product is the source of the BCC infections.

An outbreak in 2016 included serious infections in 63 confirmed cases and 45 suspected cases in 12 states. These 2016 infections were also linked to contaminated product made by PharmaTech, as confirmed by CDC and FDA testing. An FDA investigation associated with the 2016 multistate outbreak identified BCC in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech. The 2016 investigation also detected BCC in the water system used to manufacture the product. 

Additional bacteria, yeast, and mold contaminants were also found in the PharmaTech docusate sodium oral liquid samples recently tested by FDA. FDA reminds manufacturers about the importance of robust current good manufacturing practices and testing for all non-sterile liquid products, including docusate sodium, to ensure that their products conform to appropriate microbial limits and are free of any microorganisms that may cause infections.
 
FDA reminds health care professionals and patients not to use any liquid product manufactured by PharmaTech’s Davie, Florida, facility. These products are labeled by a variety of companies, including Rugby, Leader, Major, Centurion, and Mid Valley, and they should not be used due to the possibility of B. cepacia contamination and the potential for severe infections in patients.

FDA also encourages health care professionals and patients to report adverse events or quality problems experienced with the use of drug products to FDA’s MedWatch Adverse Event Reporting program: 

FDA advises health care professionals and patients of Mid Valley Pharmaceutical voluntary recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup due to potential contamination with B. cepacia

Update [9/1/2017] FDA is advising patients to immediately stop using recalled lots of Doctor Manzanilla Cough & Cold (#23221701) and Doctor Manzanilla Allergy & Decongestant Relief Syrup (#23221701). See the company’s recall notice for more information.

FDA advises health care professionals and patients of Centurion Labs’ voluntary recall of Ninjacof and Ninjacof A due to potential contamination with B. cepacia

Update [8/25/2017] FDA is advising patients to immediately stop using recalled lots of Ninjacof (Lot# 200N1601) and Ninjacof A (Lot# 201NA1601), which are used to temporarily relieve symptoms of the common cold and allergies. See the company’s recall notice for more information.

FDA announces Leader Brand, Major Pharmaceuticals, and Rugby Laboratories recall of all liquid products manufactured by PharmaTech due to B. cepacia contamination risk

Update [8/10/2017] FDA is announcing a voluntary recall of all liquid products manufactured by PharmaTech, and distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories, due to possible Burkholderia cepacia contamination. These products, including various drugs and dietary supplements intended for use in infants and children, were distributed nationwide. See the recall announcement for a complete list of recalled products with photos.

Patients, pharmacies, and healthcare facilities that have the recalled product on hand should stop using and dispensing them immediately.

Consumers with questions regarding this recall can contact the companies at the numbers below:

  • Leader Customer Support: at 1-800-200-6313, option #1, Monday through Thursday
    8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m. EST
  • Rugby Laboratories/Major Pharmaceuticals Customer Support: 1-800-645-2158, Monday through Friday
    8 a.m. – 8 p.m. EST

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of these products to FDA’s MedWatch Adverse Event Reporting program:

FDA will provide additional information when it is available.

FDA advises health care professionals and patients not to use any liquid drug products manufactured by PharmaTech and distributed by Rugby Laboratories and possibly other companies

CDC lab testing detects product contamination, links products to patient infections

[8/8/2017] FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection.

Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products – Diocto Liquid and Diocto Syrup, both oral liquid docusate products – manufactured by PharmaTech.

Additional liquid drug products manufactured by PharmaTech might also be affected. Such products might have been labeled and distributed by Rugby and other companies. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator.

Centers for Disease Control and Prevention laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia, bacteria linked to recent patient infections. Therefore, FDA recommends health care professionals and patients not use PharmaTech’s liquid drug products.

Patients, pharmacies, and health care facilities should immediately stop using and dispensing all liquid products manufactured by PharmaTech. It might be difficult to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. 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 supplier to determine the identity of the manufacturer.

Patients who are using liquid drug products and who have concerns should contact their health care professional.

In 2016, FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at PharmaTech’s Davie, Florida, facility after being implicated in CDC’s public health investigation. These products were labeled and distributed by multiple companies, including Rugby. An FDA investigation associated with a 2016 multistate outbreak identified B. cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B. cepacia in the water system used to manufacture the product.

FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products to ensure low levels of microorganisms and the absence of any that might cause infection.

FDA has received in 2017 reports of several adverse events related to oral liquid docusate sodium products. FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to 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.

FDA will provide additional information when it is available.

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