Aurobindo Pharma USA, Inc., is voluntarily recalling lot number 03119002A3 of its mirtazapine tablets due to a label error on declared strength.
Bottles labeled as “Mirtazapine 7.5 mg” may contain 15 mg tablets, FDA says.
Inadvertently issuing a higher dose of the drug than expected may increase the risk of many side effects, including sedation, agitation, increased reflexes, tremors, sweating, dilated pupils, gastrointestinal distress, nausea, and constipation.
The company is notifying its distributors of the recall by letter. Distributors/retailers that have the product are advised to return it to the place of purchase.
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