Sandoz's TB Combination Drug 4D and 4D Plus Recalled Due to Inappropriate Dosage on the Strips

The Maharashtra FDA received reports that strips of pharma major, Sandoz’s TB combination drug, 4D, sold across six states carried the wrong dosage.

On investigation, FDA inspectors found that a more powerful version of the TB drug called 4D plus also carried the wrong dosage. The FDA has ordered the suspension of the sale of drugs 4D and 4D Plus in the state and also alerted the other states where the drug is marketed.

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Tuberculosis, caused by Mycobacterium tuberculosis, primarily affects the lung. It may spread to other organs.

This information to the FDA in Maharashtra was passed on by a South Mumbai Doctor who had noticed the wrong dosage on some strips that one of his patients had bought from a pharmacy in Cumballa Hill.

The patient had come to him after falling extremely sick with bouts of vomiting as he had consumed five such strips.

Consuming drugs in wrong dosages is extremely dangerous. Not only does it render the drug ineffective, such inappropriate dosages can be one of the reasons for the TB bacterium developing great resistance to antibiotics.

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Tuberculin skin test and Interferon – Release Assays are tests used to screen for tuberculosis.

Source-Medindia

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