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Drug maker recalls mirtazapine tablets

The medication is prescribed as an antidepressant for people and off-label as an appetite stimulant for cats.

Drug maker recalls mirtazapine tablets

A small amount of a human antidepressant drug sometimes used in cats to stimulate appetite has been voluntarily recalled because of a label error.

The manufacturer, Aurobindo Pharma USA Inc., recalled mirtazapine tablets from lot number 03119002A3 and with an expiration date of March 2022. The medication contained in some bottles labeled Mirtazapine Tablets 7.5 mg might contain twice the dosage, 15 milligrams.

Mirtazapine tablets are indicated for the treatment of major depressive disorder in people, Aurobindo Pharma reported.

The Dayton, New Jersey, company issued an alert in cooperation with the U.S. Food and Drug Administration’s Center for Veterinary Medicine.

“Although this is a human product, our understanding is that it is commonly used extra-label in cats whose owners prefer the tablet formulation,” an FDA spokesperson said. “This recall does not have any relation to the approved animal product Mirataz, which is a topical formulation.

“We encourage any veterinarians or nurses/technicians who note symptoms of toxicity or other adverse events to report to FDA.”

More information is available at

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