Aurobindo Pharma USA has voluntarily recalled a lot of its depression drug Mirtazapine because the label could have the wrong strength of the medication, the company announced in a press release recently posted on the Food and Drug Administration's website.
According to the FDA, the bottles labeled as 7.5 mg pills might contain 15 mg tablets.
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“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 release said. “Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.”
Mirtazapine is prescribed for the treatment of major depressive disorders. The affected lot number is 03119002A3, which is the same for both the 7.5 mg and 15 mg strength tablets.
The manufacturer is notifying all distributors and arranging for the return of the medication.
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Consumers with medical questions about this recall or to report an adverse affect can contact Aurobindo Pharma USA at: 1-866-850-2876 Option 2 or email pvg@aurobindousa.com.
Consumers should contact their physician or health care provider if they have experienced any problems that might be related to taking Mirtazapine.
Aurobindo Pharma USA is based in East Windsor, New Jersey, and is a subsidiary of Aurobindo Pharma in India.
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India is also where many of the recently recalled blood pressure medications were manufactured.
The drugs valsartan and losartan were found to contain trace amounts of cancer causing impurities. These impurities were traced to factories in China and India that make valsartan ingredients and ship them to generic drug companies throughout the world.
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