Manufacturer PharmaTech and distributor Rugby Laboratories have issued a voluntary recall of all unexpired Diocto (docusate sodium). Diocto is a over-the-counter stool softener, used to relieve constipation.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled all lots of Diocto liquid.
Why has Diocto been recalled?
The recall was initiated because of a risk of product contamination with Burkholderia cepacia (B. cepacia). B. cepacia can cause serious or even life-threatening infections in anyone with a compromised immune system, or those with chronic lung conditions like cystic fibrosis.
When was the recall initiated?
All lots of Diocto were recalled by the manufacturer on July 12, 2016.
Are patients who have taken this medication being notified?
Yes. Rugby Laboratories is working with PharmaTech to notify customers using recall letters. They are arranging for the return of all recalled Diocto.
You can also call the Customer Support Department for Rugby Laboratories directly at 1-800-645-2158. They have representatives available Monday through Friday 8:00am – 8:00pm EST.
Which products were affected?
In this recall, all lots and the only strength of Diocto are affected.
Drug: Diocto liquid, /mL, 473 mL bottle
National Drug Code (NDC): 00536-0590-85
If you have any trouble finding information on your medication, please check with your pharmacist.
Have there been any reports of people getting sick?
Yes. The CDC has reported outbreaks in 5 states with a total of 49 cases so far.
What are the FDA and CDC recommendations?
Both the FDA and CDC are recommending that you do not use any docusate sodium liquid products for the time being.
Are all docusate sodium medications affected?
Not at this time. There is currently no evidence to suggest docusate sodium capsules or enema products have been affected.