WASHINGTON (dpa-AFX) - Aurobindo Pharma USA, Inc. recalled a certain lot of depressive disorder medication Mirtazapine in the form of tablets for a label error on declared strength, the U.S. Food and Drug Administration or FDA said in a statement.
The East Windsor, New Jersey-based generic pharma company is recalling Mirtazapine tablets of 7.5 mg and 15 mg strengths that are packaged in 500 count bottles. The recall affects tablet lot number 03119002A3 with expiration date of March 2022. The company said the bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
Mirtazapine is an antidepressant that doctors prescribe to treat depression. It belongs to a group of medicines called tetracyclic antidepressants, which help balance the chemical messengers, or neurotransmitters, in the brain that regulate mood.
The company said taking a higher dose of the medicine than expected may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. These can contribute to falls in the elderly or motor vehicle accidents in adults.
The recalled tablets are prescription oral products and was distributed directly to wholesalers, distributors, retailers across the U.S.
Aurobindo Pharma is arranging for return of all of the recalled product, and urged distributors and retailers to return them to place of purchase. They have also warned consumers to stop using the product, and contact their physician if they have experienced any problems.
In November, Aurobindo Pharma USA had recalled 38 lots of heartburn medication Ranitidine in the form of tablets, capsules and syrup for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels established by the FDA.
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