The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and Rugby Laboratories are calling for a voluntary recall of the stool softeners Diocto Liquid and Diocto Syrup.
The health agencies are partnering with Michigan-based Rugby Laboratories, which distributes the products, to warn health care providers around the country to discontinue use of these stool softeners, the American Health Association said on its website. The docusate sodium solutions, which are made by Florida-based PharmaTech LLC, are possibly contaminated with Burkholderia cepacia, which is a group of bacteria that can cause deadly infections in patients with weak immune systems or chronic lung conditions like cystic fibrosis.
Lots with Diocto Liquid 50 mg/5 mL NDC 0536-0590-85; or Diocto Syrup 60mg/15mL NDC 0536-1001-85 are included in this recall. According to the FDA, consumers, pharmacies and health care facilities should discontinue dispensing the recalled products from these lots.
"Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program," the FDA said in its notice on the Diocto products. "Consumers can contact their physician or healthcare provider if they have additional questions about this product."