Two laxatives made by Davie company PharmaTech have been recalled because they might contain a bacteria that can cause life-threatening infections in those with weakened immune systems.
And the Food and Drug Administration says it has received “several adverse event reports” of infections.
Diocto Liquid and Diocto Syrup were distributed by Rugby Laboratories to wholesalers and retailers nationwide, which means the 470 ml bottles could be on shelves at any level healthcare from hospitals to patients’ medicine cabinets. All lots with “NDC 0536-0590-85” or “NDC 0536-1001-85” are in the recall and at risk of being contaminated with Burkholderia cepacia.
“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,” the recall announcement states. “Some of these infections may be serious or even life-threatening in the at-risk patient population.”
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The notice also states, “FDA has 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 LLC.”
Individual consumers and medical personnel are asked to stop using the product. Those with questions can call Rugby's Customer Support Department at 800-645-2158, Monday through Friday, 8 a.m. to 8 p.m..
PharmaTech was incorporated as a Florida company in 2009.