SEID – UTROGESTAN® release.

Lliçà de Vall, February 23, 2018

Dear Sirs,

We inform you of the non-urgent withdrawal of the lots:

– Utrogestan 100 mg 30 capsules CN 700513: K016, L001, L002, L003 – Utrogestan 200 15 capsules CN 783001: L001, L002 and K012
– Utrogestan 200 mg 60 capsules CN 696075: L003, L004, K009, K010 and K011

Lliçà de Vall, February 23, 2018

Dear Sirs,

We inform you of the non-urgent withdrawal of the lots:

– Utrogestan 100 mg 30 capsules CN 700513: K016, L001, L002, L003
– Utrogestan 200 15 capsules CN 783001: L001, L002 and K012
– Utrogestan 200 mg 60 capsules CN 696075: L003, L004, K009, K010 and K011

For having detected that the manufacturer of the bulk has used a progesterone manufacturer not included in the marketing authorization.

During the quality controls that Seid applies to all its medicines, this discrepancy with respect to the marketing authorization of said medicines was detected and it was immediately communicated to the Health Authorities.

It is an administrative matter that in no case compromises the quality of the medicine or poses a risk to patients. The progesterone used in the affected batches meets the highest European quality standards.

We inform you that after becoming aware of this fact, Seid took the necessary measures to correct it. Since the first days of January 2018, the lots that are being distributed have been manufactured in full compliance with the Correct Manufacturing Standards and with the marketing authorization.

We remain at your entire disposal for any questions or clarification you may require.

Sincerely,
Seid S.A.