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The company is voluntarily recalling a docusate sodium solution distributed by Rugby Laboratories due to risk of contamination.
On July 15, FDA announced that PharmaTech LLC (Davie, FL) is voluntarily recalling all lots of its docusate sodium solution (Diocto Liquid) due to the risk of Burkholderia cepacia contamination. The product is branded as Rugby and distributed by Rugby Laboratories. Patients with compromised immune systems that are treated with product contaminated with B. cepacia may develop life-threatening infections, according to a press release. The recall includes all lots with NDC 0536-0590-85.
The potential contamination was discovered after the company received two isolated complaints about the product. FDA also received several adverse event reports of B. cepacia infections. Some of the FDA reports were associated with liquid docusate products manufactured by companies other than PharmaTech.
Diocto Liquid, which is used as a stool softener, is distributed nationwide to wholesale and retail facilities including hospitals and pharmacies. Rugby Laboratories is working with PharmaTech to notify distributors and customers about the return. The companies are recommending that the product not be used or dispensed. Adverse events can be reported to FDA at www.fda.gov/medwatch/report.htm.