This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|August 11, 2017
FDA Recalls PharmaTech Liquid Products for B. cepacia Contamination Risk
Author(s)Pharmaceutical Technology Editors
On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.
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On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination. The recalled products were distributed nationwide at wholesale and retail facilities including hospitals and pharmacies.
These products, which include various drugs and dietary supplements intended for use in infants and children, have been linked to a PharmaTech-manufactured product connected to severe adverse event reports of B. cepacia infections in patients. After being alerted to the issue by FDA, Rugby Laboratories issued a voluntary recall on August 3, 2017 of Diocto Syrup and Diocto Liquid (docusate sodium solutions). As a precautionary measure based on additional information received from FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by the manufacturing company. The distribution firms have sent out recall letters and arranged for the return of all recalled products.
Consumers, pharmacies, and healthcare facilities that have the recalled product should cease use and
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