Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

If you have a pack of Pamol® containing 300 tablets with batch number 11255945 (expiry date 07/2021), the Danish Medicines Agency encourages you not to take the tablets and to return the tablets to a pharmacy. You should consult your doctor if you have taken one or more tablets from the affected batch.

In Denmark, Pamol® in packs of 300 film-coated tablets is a prescription-only medicine, which is sold at pharmacies only. The products are also sold to hospital pharmacies in Denmark. The specific batch number has been sold in Denmark only.

The Danish Medicines Agency has an ongoing dialogue with the company and will provide an update on the situation, if relevant.

At present, only a few packs of Pamol® containing a small number of Ibumetin tablets have been identified.

Information for patients

If you have a pack of Pamol® containing 300 tablets with batch number 11255945 and expiry date 07/2021, you should return the medicine to a pharmacy. Ask your relatives or the pharmacy in case of doubt. You should consult your doctor if you have taken tablets from one of the affected packs. Do not take more of the tablets. You should return the pack of medicine to a pharmacy to have it replaced by a different batch number.

Information for pharmacy staff

The Danish Medicines Agency encourages pharmacy staff to help patients check the batch numbers. Packs of Pamol® containing 300 tablets from batch number 11255945, expiry date 07/2021, should be replaced. The Danish Medicines Agency encourages hospital pharmacies to check whether they have any packs of the affected batch number in the departments.

Information for doctors

The Danish Medicines Agency encourages doctors to help inform patients of the recall. Doctors should encourage patients to have any packs of Pamol® containing 300 film-coated tablets replaced at a pharmacy.