Aurobindo Pharma, is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
Mirtazapine tablets are indicated for the treatment of major depressive disorder.
Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.
The affected lot number for both Mirtazapine Tablets 7.5 mg and Mirtazapine Tablets 15 mg are 03119002A3 Exp 03/2022.
What is drug labelling error?
Drug labeling refers to all the printed information that accompanies with drug, including the label, the wrapping and package insert. The label has two main functions. One is to uniquely identify the contents of the container and their doses and other to ensure that patients have clear and concise information which will enable them to take or use their medication in the most effective and appropriate way. If any error occurs it will be considered professional negligence which is defined as absence of reasonable care and skill or willful negligence of medical practitioners in the treatment of patient which causes bodily injury or death of the patient.
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