Healthcare major Abbot has initiated a voluntary recall on a mislabelled batch of thyroid medicine Thyronorm, 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 labelling error that mislabelled the dose strength (mcg or microgram,” the company said.

“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 mislabelled batch,” it said, adding that there were no quality issues with the product and that they had not received any reports of patient impact.

The company said it was working with distributors and 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 added.

Site investigation

On zeroing in on the faulty product, the company said, “the incorrect labelling was due to a human error by one of the third-party manufacturer plant operators, we are in the process of conducting an exhaustive investigation at the site, and will take corrective actions as required.” The company has been in touch with the respective Food and Drug Administrations, the spokesperson added.

Last year, counterfeit versions of the same brand were under the scanner of authorities in Telangana. 

On the latest incident, the company said, they monitor and test the quality of products at all manufacturing and supply stages to ensure it meets their standards and complies with all applicable regulations. “We will take all necessary action at the third-party manufacturing site to ensure appropriate remediation once we have concluded the investigation,” the spokesperson added.