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Voluntary recall of liquid products manufactured by PharmaTech and distributed by three companies

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Three distribution firms—Leader Brand, Major Pharmaceuticals, and Rugby Laboratories—have jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its registered facility in Davie, FL, due to possible product contamination.

Three distribution firms—Leader Brand, Major Pharmaceuticals, and Rugby Laboratories—have jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its registered facility in Davie, FL, due to possible product contamination. Through recent communication with FDA, Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech. FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients, which could be linked to PharmaTech-manufactured docusate sodium solutions (Diocto Syrup or Diocto Liquid). Rugby then issued a voluntary recall of the PharmaTech-manufactured docusate sodium solutions. As a precaution based on additional data received from FDA, the three distribution companies are recalling all lots within expiry of all liquid products manufactured by PharmaTech. Additional information about the recall is available here.

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https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570997.htm

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