The company said it is notifying its distributors by letter and is arranging for return of all of the recalled product.
Aurobindo Pharma USA Inc said it is voluntarily recalling Mirtazapine tablets, used for the treatment of major depressive disorder, in the US market.
The product is being recalled due to a label error on declared strength.
Bottles labelled as Mirtazapine 7.5 mg may contain 15 mg tablets, as per the company's announcement posted on the website of the United States Food and Drug Administration (USFDA).
The company is recalling lot number 03119002A3 of tablets to the consumer level, it added.
"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 announcement said.
Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults, it added.
The company said it is notifying its distributors by letter and is arranging for return of all of the recalled product. Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase.
The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products, it added.
"Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," the announcement said.Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottle, it added.
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