RECALL of Diocto Liquid Docusate

PharmaTech LLC, the manufacturer of the branded product Diocto Liquid (docusate sodium solution), is recalling all lots of Diocto due to a risk of product contamination with Burkholderia cepacia.  Contract Pharmacy Services purchased limited supplies of this product in the past.  Those facilities that may have received this product will be contacted directly by CPS so that the product can be removed from active stock.

If there is a chance that you have purchased this product from a source other than CPS please be sure to thoroughly search your inventory and remove it from active stock.

Please inspect any liquid docusate for Diocto 50 mg/5 mL solution supplied in 473mL (1 pint) bottles NDC # 0536-0590-85.  Discard any unused solution immediately.

The Centers for Disease Control (CDC) is continuing the investigation into a multistate outbreak of infections caused by Burkholderia cepacia that may be linked to contaminated liquid docusate (Colace).   At this time, the FDA and the Centers for Disease Control and Prevention (CDC) is continuing to recommend that clinicians do not use any liquid docusate sodium product for any medical purposes. The Agency and the CDC are continuing to investigate this issue to identify other potentially contaminated products.

 If a stool softener is needed and the patient is unable to swallow pills, an alternative would be to use a docusate 100 mg gelcap.  The gelcap can be punctured and the contents added to food.  Please note that this will not provide an accurate dose of docusate because much of it will remain adhered to the gelcap wall.

Please contact Kimberly Griego, PharmD at or 267-487-9033 with any questions.

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