Business

Aurobindo’s U.S. arm recalls Mirtazapine

Aurobindo Pharma USA Inc is voluntarily recalling Mirtazapine tablets, which are indicated for treatment of major depressive disorder, due to a label error.

According to information on the USFDA site, the recall is of lot number 03119002A3 of Mirtazapine tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets. Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. The company is notifying its distributors by letter and arranging for return of all of the recalled product. Mirtazapine tablets are packaged in 500 count bottles.

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Printable version | Feb 21, 2020 2:40:07 PM | https://www.thehindu.com/business/aurobindos-us-arm-recalls-mirtazapine/article30472943.ece

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