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Stool Softener Recall Due to Bacterial Contamination


On August 3, 2017, Rugby Laboratories recalled all lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC, due to a risk of product contamination with Burkholderia cepacia. The FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients which may be linked to Diocto Liquid or Diocto Syrup manufactured by PharmaTech.

 

Diocto Liquid and Diocto Syrup are used as stool softeners and are packaged in one pint (473 mL) bottles. Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies.

 

If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population.

 

All lots with NDC 0536-0590-85 and NDC 0536-1001-85 are included in this recall.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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