Stool Softeners Recalled Due to Possible Contamination

Diocto Liquid and Diocto Syrup are indicated for use as stool softeners
Diocto Liquid and Diocto Syrup are indicated for use as stool softeners

Rugby Laboratories announced a voluntary recall of all lots of Diocto Liquid and Diocto Syrup (docusate sodium solutions) due to a risk of contamination with Burkholderia cepacia. The recall was initiated because of several adverse event reports linking these products to patients with B. cepacia infection.

Diocto Liquid and Diocto Syrup are indicated for use as stool softeners. Administration of products with potential contamination can lead to serious or potentially fatal infections in immunocompromised patients or in patients with chronic lung conditions such as cystic fibrosis.

The recall affects all lots of Diocto Liquid 50mg/5mL with NDC 0536-0590-85 and Diocto Syrup 60mg/15mL with NDC 0536-1001-85. They were distributed to wholesale and retail facilities across the U.S. 

Diocto Liquid and Diocto Syrup are manufactured by PharmaTech, LLC, and are supplied in 473mL bottles. Pharmacies, hospitals, and consumers who have the affected products should stop use immediately.

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For more information call (800) 645-2158 or visit FDA.gov.