ABBOTT STATEMENT

Voluntary recall of one batch [No. AEJ0713; Mfg. Date: March 2023] of Thyronorm Tablets (Thyroxine Sodium)

 

Abbott has voluntarily recalled 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). 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 initiated a voluntary recall of the mislabeled batch.
  • We are working with our distributors and other partners to facilitate this recall.
  • The concerned batch has a total of 3636 bottles of which we have blocked or recalled  ~ 3500 bottles. Our teams are working continuously to trace the balance bottles.
  • This batch was distributed in April 2023 only in Madhya Pradesh and Telangana.
  • This issue does not affect or extend to any other batch or dosage strength of Thyronorm  or other Abbott products.

We have also set up a helpline to address any queries or concerns of patients and the medical community. For any information or guidance, please contact Abbott at: +91 22 50461000  / 50462000 or webmasterindia@abbott.com

 

Published on April 27, 2023

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