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FDA Announces Expanded Recall of PharmaTech Products

The Food and Drug Administration (FDA) has updated a voluntary recall notice for Diocto products to include all liquid drug products and dietary supplements manufactured by PharmaTech and distributed by Rugby, Leader Brand, and Major Pharmaceuticals.

FDA earlier this month alerted health care providers about a voluntary recall of Diocto liquid and syrup because of a risk of contamination with Burkholderia cepacia. The product is used as a stool softener, and a B. cepacia contamination could cause serious or life-threatening infections in patients with compromised immune systems or chronic lung conditions.

The voluntary recall has been expanded to include various dietary supplements, such as liquid vitamin D drops and liquid multivitamins marketed for infants and children.

FDA directs health care providers to immediately stop use of these products and to report adverse events or quality problems to the MedWatch Adverse Event Reporting program.

Contact Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Michelle Rosenfeld is senior writer/editor at America's Essential Hospitals.