Distributors Voluntarily Recall Products Manufactured by PharmaTech
Several distributors have issued a nationwide voluntary recall of certain products manufactured from PharmaTech, a Davie, Florida-based contract manufacturer.
PharmaTech’s distribution firms, Leader Brand, Major Pharmaceuticals, and Rugby Laboratories, are jointly issuing a recall of all lots within expiry of all liquid products manufactured by PharmaTech at its Florida facility. The distribution firms are partnering with the FDA to notify customers who may be in possession of liquid products manufactured by PharmaTech.
The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. Through recent communication with the FDA, the distribution firm, Rugby Laboratories, learned of a potential issue with a product manufactured by PharmaTech. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech-manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions), a product for treating occasional constipation. In response, Rugby Laboratories issued a voluntary recall on August 3, 2017 of the PharmaTech-manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech.
The distribution firms are notifying their distributors and customers by recall letters and are arranging for return of all recalled products.