In two additional batches of Clonotril 2 mg Tablets, Remedica Limited is extending the voluntary recall of medicinal products announced on August 10, 2026.
In a clarifying announcement, dated August 13, the pharmaceutical industry announced that the following numbers have been added to the list of recalled batches:
126382
126383
The latest update does not include another medicinal product or additional change to the original list. For all other batches and preparations, the announcement issued on August 10 is still valid.
Remedica emphasizes that the actions taken for all recalled batches are of a preventive nature.
The original notice stated that the recall was decided due to certain out-of-bounds results in the product stability studies, without any cause for concern at this stage.
Stability studies are carried out to determine whether a medicinal product retains its intended quality characteristics throughout its shelf life when stored under the specified conditions.
The new communication does not provide more information on the results of the tests nor does it specify why the two batches of Clonotril were added.
No to discontinuation without medical guidance
The company draws the attention of patients, emphasizing that treatment with products from the affected batches should not be discontinued without prior medical guidance.
Patients who have a package with one of the recalled batch numbers are asked to contact their treating physician. The doctor will guide them as to the most appropriate option for the safe continuation of their treatment.
No arbitrary change of medication or dosage should be made, as abrupt discontinuation of certain treatments may pose risks. The replacement of the preparation should be decided by a healthcare professional, depending on the needs of each patient.
Citizens can find the batch number on the packaging of the medicine and, if it is on the recall list, ask their doctor or pharmacist for instructions.
Remedica states, finally, that the decision is part of the actions it is taking to ensure patient safety and maintain the trust of its partners.
