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FDA announces voluntary nationwide recall of all liquid products manufactured by PharmaTech and distributed by six companies

  • [UPDATE 8/9/2016]  FDA is alerting health care professionals and consumers of PharmaTech’s voluntary recall expansion to include all liquid products due to possible Burkholderia cepacia contamination. These products were manufactured in its Davie, Florida, facility, and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

Consumers, pharmacies, and health care facilities that have product which is being recalled should stop using and dispensing them immediately. Using these products in a patient whose immune system is compromised could result in infections, which may be life-threatening.

To date, FDA has received adverse event reports related to oral liquid docusate sodium and is not aware of any adverse event reports related to the additional recalled products.

FDA and CDC will provide additional information when it is available.

FDA announces voluntary nationwide recall of oral liquid docusate sodium manufactured by PharmaTech and distributed by Rugby Laboratories

[7/16/16]  U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution 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.

PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.

In addition, 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. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.

Patient safety is our top priority. FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

FDA and CDC will provide additional information when it is available.

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:

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