Abbott India has recalled one batch of its popular thyroid disorder drug Thyronorm due to a labeling error about dosage, saying there was no quality issue.
The mislabeled batch was invoiced in Madhya Pradesh and Telangana. “Abbott is recalling one batch (No. AEJ0713; Mfg. Date: March 2023) of Thyronorm, a medicine used in the treatment of hypothyroidism, in India, due to a labeling error that mislabeled the dose strength (mcg or microgram),” said the pharmaceutical company.
“There are no quality issues with the product, and we haven’t received any reports of patient impact. A small percentage of bottles from the concerned batch (No. AEJ0713) of 88mcg tablets have an incorrect 25mcg label. It is important that people take the correct dose, so we have initiated a voluntary recall of the mislabeled batch,” it said.
The company said it is working with distributors to facilitate the recall. “This issue does not affect or extend to any other batch or dosage strength of Thyronorm or other Abbott products.”
Thyronorm is prescribed to patients with hypothyroidism, a condition where the thyroid gland does not produce sufficient quantities of the required hormones. Deficiency of thyroid hormones can disrupt heart rate, body temperature and metabolism. Hypothyroidism is most prevalent in older women. Major symptoms include fatigue, cold sensitivity, constipation, dry skin and unexplained weight gain.
An overdose of the medication can cause chest pain, irregular heartbeats, headache, muscle cramps, anxiety, sweating, diarrhoea, sleeplessness, etc.
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According to IQVIA, Thyronorm is the eighth largest selling drug brand in India as of March 2023 with sales of Rs 564.73 crore according to moving annual turnover (MAT) data.