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Aurobindo Pharma USA recalls Mirtazapine tablets

The label states incorrect tablet strength

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Photo source: FDA
Aurobindo Pharma USA is recalling a single lot of Mirtazapine tablets.

The product, which is used for the treatment of major depressive disorder 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 affected lot number for both 7.5 mg and 15 mg is 03119002A3. With an expiration date of march20222.

What to do

The company. is notifying its distributors by letter and arranging for return of all of the recalled product.

Consumers with medical questions may contact Aurobindo Pharma at (866) 850-2876 Option 2, or by email at pvg@aurobindousa.com

Consumers with general questions regarding the return of the recalled product may contact Qualanex at (888) 504-2014 Monday – Friday 7:00 am – 4:00 pm (CST) or by email at mecall@qualanex.com.

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