FDA Warns Of Bacterial Contamination In PharmaTech Liquid Drug Products
Federal health officials are warning the public not to use any liquid forms of drugs manufactured by PharmaTech, after discovering that the water system used by the pharmaceutical company to create medications contained the bacterium Burkholderia cepacia, which may pose a risk of serious and potentially fatal side effects.
An FDA advisory was issued on August 8, following several recent reports of B. cepacia infections among patients who received certain liquid docusate medications manufactured by PharmaTech LLC. To date, no serious injuries or fatalities have been reported.
The warning was initiated after Rugby Laboratories of Livonia, Michigan voluntarily announced a recall of certain Diocto Liquid and Diocto Syrup products, which were manufactured by PharmaTech. This action was taken after several consumer reports indicated patients became ill with B. cepacia infections shortly after use.
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PharmaTech, in conjunction with officials from the FDA, performed routine testing on multiple lots of the liquid docusate products and found several strains of the infection within the products. Further investigations discovered the liquid medications had become contaminated by the local water system used to manufacture the medications, which was tested and found to contain similar strains of B. cepacia.
B. cepacia bacterium is an organism that is typically found in aquatic environments and can cause mild to severe infections in patients depending on the state of the individual’s health. Healthy individuals are typically not impacted by the bacterium, however, individuals with weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be at increased risk levels requiring hospitalizations and immediate medical care.
Symptoms of Burkholderia cepacia infection are similar to the symptoms you would experience with many other common bacteria’s, causing symptoms including cough,congestion, difficulty breathing and fever. In severe cases, individuals may develop cepacia syndrome, which can lead to very severe symptoms including high fevers.
Docusate products are generally used as for stool softeners and constipation relief medications and are often sold in either liquid gel capsule forms or as a syrup for easy consumption. The products are an over-the-counter drug and can be purchased at local pharmacies or grocery stores.
The public is being asked to stop using any liquid form of medication manufactured by PharmaTech LLC immediately, and to contact their local pharmacy or healthcare professional to determine whether the medication was manufactured by PharmaTech, since not all products are labeled with the manufacturer branding.
Companies who have acquired the medications are being asked to immediately quarantine the products and to contact their local FDA pharmaceutical recall coordinator.
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