Potential Contamination Prompts Recall of PharmaTech Product
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Potential Contamination Prompts Recall of PharmaTech Product

The company's recall applies to all lots of Diocto Liquid within expiry

July 18, 2016

PharmaTech has issued a recall of all lots within expiry of Diocto Liquid, a docusate sodium solution under the Rugby brand, due to a risk of product contamination with burkholderia cepacia.

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.

Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.

The Food and Drug Administration (FDA) has informed PharmaTech and Rugby that it received several adverse event reports of B. cepacia infections in patients.

Consumers, pharmacies, and healthcare facilities possessing the products should stop using and dispensing them immediately.

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

For more information, consumers may contact Rugby's Customer Support Department at (800) 645-2158.