PharmaTech Liquid Products – Potential contamination with Burkholderia cepacia - UPDATED

**Due to an update in May 2019 to the FDA.gov website, provided links may not appropriately redirect. Please visit www.fda.gov/drugs/drug-safety-and-availability to see the most recent FDA Medication Safety Alerts and Safety Communications or to search for specific alerts or communications.**

The PharmaTech recall of oral liquid docusate products has been expanded. FDA now recommends not using any liquid products manufactured by PharmaTech. The concern is potential contamination with Burkholderia cepacia. This is a new alert from the 2016 recall of all liquid docusate products manufactured by PharmaTech. Use of products contaminated with B cepacia can cause clinical infection in immunocompromised patients, especially patients with lung conditions such as cystic fibrosis. These infections can be life-threatening in certain patients. FDA received several reports of B cepacia infections in patients who were using the affected liquid docusate products. Laboratory testing by CDC found B cepacia in oral liquid docusate made by PharmaTech. Because FDA is concerned other liquid products manufactured by PharmaTech may also be contaminated, they are advising patients and healthcare professionals not to use any liquid products manufactured by PharmaTech.

The liquid products were distributed nationwide to wholesalers and retail outlets. Centurion Labs, Leader Brand, Major Pharmaceuticals, Mid Valley Pharmaceutical, and Rugby Laboratories are known distributors of PharmaTech products. The 5 suppliers have issued recalls of all liquid products manufactured by PharmaTech. Patients and healthcare facilities should stop using and quarantine these products until more is known. The affected products are likely not labeled with the name PharmaTech, making it difficult to determine if a product is potentially affected and should be quarantined. Contact the distributor of the product to determine if it was manufactured by PharmaTech. A list of some of the affected products is available on FDA’s website. In addition, a full product list from the 2016 recall is available in the August 8, 2016 FDA press release.

Additional information about the current recommendation not to use liquid PharmaTech products, including a list of some affected products and distributors:

  • MedWatch Safety Alert – August 30, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574257.htm
  • MedWatch Safety Alert – August 23, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm572909.htm
  • MedWatch Safety Alert – August 10, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570997.htm
  • Company Press Release – August 10, 2017
    www.fda.gov/Safety/Recalls/ucm571001.htm

Additional information about the recommendation not to use liquid PharmaTech products:

  • MedWatch Safety Alert – August 8, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570674.htm
  • FDA Advisory – August 8, 2017
    www.fda.gov/Drugs/DrugSafety/ucm570672.htm

Additional information about the oral liquid docusate 2017 recall:

  • MedWatch Safety Alert – August 3, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/
    SafetyAlertsforHumanMedicalProducts/ucm570014.htm
  • Company Press Release – August 2, 2017
    www.fda.gov/Safety/Recalls/ucm569967.htm

Additional information about 2016 recall:

  • MedWatch Safety Alert – August 9, 2016
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515625.htm
  • FDA Press Release – August 8, 2016
    www.fda.gov/Safety/Recalls/ucm515610.htm
  • FDA Drug Safety Communication – July 15, 2016
    www.fda.gov/Drugs/DrugSafety/ucm511525.htm
  • FDA Drug Safety Communication – July 16, 2016; updated August 9, 2016
    www.fda.gov/Drugs/DrugSafety/ucm511527.htm
  • Centers for Disease Control and Prevention – Multistate Outbreak of Burkholderia cepacia Infections – July 16, 2016
    www.cdc.gov/hai/outbreaks/b-cepacia/index.html
  • MedWatch Safety Alert – July 16, 2016
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm511528.htm