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July 17, 2016: FDA Alerts Healthcare Professionals Of Diocto Recall

Diocto Recall News

In a Safety Alert to healthcare professionals, the U.S. Food and Drug Administration (FDA) announced that PharmaTech LLC, Davie, Florida, is recalling all non-expired lots of Diocto Liquid, a docusate sodium solution, distributed by Rugby Laboratories, Livonia, Michigan. The FDA confirmed that the recalled product is contaminated with Burkholderia cepacia, a type of bacteria linked to a multi-state outbreak.

The FDA reported that is has received several adverse event reports of B. cepacia infections in patients. Liquid docusate sodium products, manufactured by companies other than PharmaTech, have also been identified in reports to the FDA. FDA and the U.S. Centers for Disease Control and Prevention (CDC) are working to identify other potentially B. cepacia contaminated liquid docusate sodium products.
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Diocto Recall Information

According to the FDA Safety Alert, PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.

Both the FDA and CDC recommend that “clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.” FDA and CDC will provide additional information about these products as it becomes available.

The FDA further recommened that healthcare professionals and patients report docusate adverse events or docusate side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:

•Completing and submitting a report online at www.fda.gov/MedWatch/report
•Downloading the form or calling 1-800-332-1088 to request a reporting form. You can complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Call The Weinberg Law Firm For Pharmaceutical Drug Lawsuit Information

Attorney Eric Weinberg has been assisting personal injury victims since 1984. We are ready to help you too. Focusing primarily on pharmaceutical drug litigation, The Weinberg Law Firm has obtained over 800 million on behalf of clients. If you have a question regarding a potential Burkholderia cepacia infection lawsuit or docusate product lawsuit, please call our law firm at 1-877-934-6274. Our phones are answered 24/7.

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