The product in question - Diocto Liquid (NDC 0536-0590-85) – has been linked to 46 cases of B. cepacia according to the US Centers for Disease Control and Prevention (CDC), which advised doctors not to use it.
“[The] CDC continues to recommend that clinicians not use any liquid docusate product as a stool softener or for any other medical purpose. This recommendation is now expanded to all patient populations.
The organisation added that: “If an oral liquid docusate stool softener is medically necessary, alternative medicines should be used.”
Florida-based contract manufacturing organisation (CMO) PharmaTech makes the product for Livonia, Michigan-based Rugby Laboratories. Details of the recall were posted on the US Food and Drug Administration (FDA) website on July 15.
The firm said: "All lots with NDC 0536-0590-85 are included in the recall" adding that it "learned of the potential issue through the receipt of two isolated complaints regarding this product.
PharmaTech's manufacturing facility is in Davie, Florida.
In March, the firm announced the facility had passed an FDA inspection and was found to be "compliant with the principles and guidelines of Current Good Manufacturing Practices (cGMP), and no Form 483 observations were issued."
PharmaTech did not respond to a request for comment.
The FDA also said it has received several adverse event reports of B. cepacia infections in patients who treated with docusate products manufactured by companies other than PharmaTech. The Agency did not provide additional information.