Dear Pharmacist Letter on reduction of the shelf-life of Athyrazol medicinal product from five to one year and measures with regard to dispensing and returning of medicinal product older than one year
The "Jadran" - Galenski laboratorij d.d. Company, the marketing authorisation holder of Athyrazol, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED), has sent out a letter to pharmacists informing them about the recall for precautions of Athyrazol batches older than one year.
The shelf-life of Athyrazol is being shortened from five year to one year and batches older than one year are for precautions being recalled from the Croatian market. During the continuous monitoring of the product quality, a stability testing was carried out, which indicated the presence of a higher content of degradation products with respect to the product specification. Due to the afore mentioned, the Agency for Medicinal Products and Medical Devices (HALMED) and JGL d.d., the marketing authorisation holder for Athyrazol have carried out a toxicologic evaluation and risk assessment for patients, after which HALMED has concluded that the content of the afore mentioned degradation products do not present a toxicological risk for patients. However, for precautions, the shelf-life of Athyrazol is being shortened from five to one year and batches older than one year are being withrawn from the market.
Agency for Medicinal Products and Medical Devices (HALMED) for precautions , recommends that patients having Athyrazol tablets at home verify whether their batch number and the shelf-life correspond to the following list and if so, return them to their pharmacy.
The list of Athyrazol tablets older than one year, mentioned in the form: batch number (shelf-life):
6187 (12/2012), 61872 (12/2012), 06182 (03/2013), 1868 (07/2013), 2788 (10/2013), 01092 (01/2014), 0319 (02/2014), 0109 (01/2014), 08193 (04/2014), 1059 (05/2014), 1699 (08/2014), 2309 (11/2014), 03702 (02/2015), 09502 (04/2015), 09503 (04/2015), 1400 (05/2015), 3270 (12/2015), 0211 (02/2016), 02012 (02/2016), 0931 (03/2016), 0941 (03/2016), 2951 (07/2014).
With this letter, we would like to inform pharmacists about measures related to dispensing and returning of the medicinal product older than one year.
Here you will find the text of the letter (in Croatian).
HALMED has not received any ADR report to Athyrazol tablets that would indicate a harmful effect of the higher than specified degradation products content.
HALMED will continue to closely monitor the safe use of the Athyrazol medicinal product and will inform the public promptly about every new evidence.
We would like to remind health care professionals that they are required by legislation to report to HALMED every adverse drug reaction (ADR). Patients that have experienced any adverse drug reaction to medicines may report it directly to HALMED by using the forms accessible from the HALMED web site in the part For patients (in Croatian only).