PharmaTech LLC, a contract manufacturer based in Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The US Food and Drug Administration (FDA) has 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.

Rugby Laboratories is working with PharmaTech LLC to notify customers who may be in possession of Diocto Liquid NDC 0536-0590-85; 50 mg/5 mL for all lots within the expiration period. Diocto Liquid is used as a stool softener and is packaged 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 company learned of the potential issue through the receipt of two isolated complaints regarding this product. The FDA has informed PharmaTech and Rugby that it received several adverse event reports of B. cepacia infections in patients. Additionally, some of these reports identify liquid docusate products manufactured by companies other than PharmaTech.

PharmaTech is notifying its distributors and customers by recall letter and is arranging for return of all recalled products.

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 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.

Source: FDA and Rugby Laboratories