Stool Softener Recall; Bacteria Contamination; 5-State Outbreak

On July 16, 2016, the FDA alerted health care professionals that PharmaTech LLC, of Davie, Florida, recalled all non-expired lots of Diocto Liquid, a docusate sodium solution stool softener distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.


Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.


In addition, the FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. The FDA and the CDC continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.


PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles. All lots with NDC 0536-0590-85 are included in the recall. Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies.


The FDA joined the CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose. The FDA and CDC will provide additional information when it is available.


See the FDA Safety Alert


Also see the Recall


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication