Abbott India recalls batch of thyroid drug Thyronorm over labeling error, details
Mumbai: Abbott India Ltd. has recently informed through a public notice that the company has issued a voluntary recall of one batch of Thyronorm tablets (Thyroxine Sodium) used in the treatment of hypothyroidism.
"This is due to a labeling error in a small percentage of bottles from this batch which have been mislabeled with the dose strength as 25mcg, whereas the bottles contain 88mcg tablets," the public notice has stated
" This batch has been invoiced only in M.P. and Telangana. The affected batch is Batch No. AEJ0713 and its manufacturing date is March 2023. This issue does not affect or extend to any other batch or dosage strength of Thyronorm or other Abbott products," the public notice added
"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). 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.
We are working with our distributors and other partners to facilitate this recall. This batch has been invoiced only in MP and Telangana. This issue does not affect or extend to any other batch or dosage strength of Thyronorm or other Abbott products," the company spokesperson said
Mistaken consumption of higher dosage can lead to overmedication of the drug. The signs and symptoms of thyroxine toxicity may not appear for several days after ingestion, and, therefore, close observation of the patient may be necessary.
The common clinical signs following thyroxine overdose could be tachycardia, agitation, nervousness, insomnia, anxiety, tremor. Severe features of thyroxine overdose may likely lead to thyroid storm involving cardiac, neurological, respiratory and thermoregulatory centers. Thyroid storm is an acute, life-threatening state of complication that presents with multi-system involvement. The mortality associated with thyroid storm is estimated to be 8 to 25% despite modern advancements in its treatment and supportive measures.
In vulnerable pediatric population, severe symptoms of thyroxine overdose may lead to coma, convulsions, acute psychosis.
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