FDA recalls liquid pharma products after bacterial contamination detected

pharmafile | August 17, 2017 | News story | Medical Communications, Sales and Marketing FDA, life sciences, pharma, pharmaceutical 

The FDA has announced that it has been forced to recall a range of liquid pharmaceutical and dietary supplement products due a possible bacterial contamination which could pose a threat to vulnerable patients through threat of serious infection.

The range of products, manufactured by US firm PharmaTech, include vitamin D drops, multivitamins, and stool softeners for infants and children. Of these products, Diocto Liquid and Diocto Syrup have been found to be contaminated with burkholderia cepacia, bacteria which pose risks to immunocompromised individuals and those with chronic lung diseases, often causing pneumonia, though healthy hosts are usually unaffected.

This discovery has prompted a voluntary recall of the products, with FDA Commissioner Scott Gottlieb noting in a statement: “B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems. These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online, making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products.”

The US Centers for Disease Control and Prevention has warned that the bacteria can spread from person to person by direct contact and often proves resistant to common antibiotics. The FDA has advised all patients and physicians to cease all use of the products immediately.

Matt Fellows

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