The Merck Serono sas laboratory, in collaboration with the National Agency for the Safety of Medicines and Health Products (ANSM), has issued a batch recall for the drug Levothyrox 25 µg, scored tablet, in a box of 90 tablets (CIP: 3400930065570). This recall is being carried out as a precautionary measure and specifically concerns batch G01U7X, the expiration date of which is December 2025.
By Thomas Kassab, published June 13, 2024
Reason for recall
During a stability study carried out by the laboratory, it was discovered that the level of Levothyroxine sodium present in batch G01U7X was slightly higher than established specifications. Although this variation is minimal, it nevertheless warrants a recall as a precautionary measure to ensure the safety and effectiveness of the treatment in patients.
Impact of the recall
It is crucial to note that only batch G01U7X is affected by this recall. Other batches of Levothyrox 25 mcg and other dosages are not affected and do not present this quality defect.
Instructions for pharmacists
Community pharmacists are asked to immediately contact patients who may have boxes of the affected batch. Patients should be instructed to return boxes of lot G01U7X to their pharmacy for an exchange.
Distribution of the batch concerned
Lot G01U7X was distributed to wholesale distributors between July 17, 2023 and August 28, 2023. Pharmacies that received this lot must follow the return procedures described below.
Return conditions
- For pharmacies : Returns and exchanges of boxes from the batch concerned must be made via wholesale distributors.
- For wholesale distributors : Boxes, including those returned by pharmacies, must be destroyed. Certificates of destruction must be sent to the Merck Serono sas Customer Relations Department within 15 days to obtain credit.
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