The shelf-life of Athyrazol is being reduced from five to one year for precautions, batches older than one year are being recalled from the market
The shelf-life of Athyrazol is being reduced 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 reduced 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).
HALMED and JGL have informed pharmacists about the reduction of the shelf-life of Athyrazol medicinal product and about the recall for precautions of batches older than one year and instructed them to inform patients about it.
HALMED has not received any ADR report for Athyrazol tablets that would indicate a harmful effect of the higher than specified degradation products content. All batches of Athyrazol tablets having the new shelf-life that will remain on the Croatian market and will be accessible to patients, completely fulfill the criteria of quality, safety and efficacy.