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“This is due to a labelling error in a small percentage of bottles from this batch which has been mislabeled with the dose strength as 25 mcg, whereas the bottles contain 88 mcg tablets,” the Mumbai-based company stated.
It said that batch was sold only in Madhya Pradesh and Telangana.
The company has requested the patients who have recently purchased Thyronorm with batch no AEJ0713 to return the bottle to the chemist they purchased it from or notify the company.
When contacted over the issue by PTI, the drug firm confirmed the development and noted that the recall is due to a labelling error and there are no quality issues with the product.
“We haven’t received any reports of patient impact. A small percentage of bottles from the concerned batch (No. AEJ0713) of 88 mcg tablets have an incorrect 25 mcg label. It is important that people take the correct dose, so we have initiated a voluntary recall of the mislabeled batch,” it stated.
The company is working with its distributors and other partners to facilitate this recall, it added. “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 stated.
(Inputs from PTI)
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