Diclofenac Sandoz, DiclacHexal

Recall | Medicines | 21/05/2015

Sandoz GmbH has informed all supplied customers in a letter dated 20.05.2015 that deviations in the release of the active ingredient were found in stability tests for batches with the old shelf life of 36 months. These deviations are due to the aging process of the tablet film layer, which is intended to prevent premature release of the active ingredient into the stomach (gastric juice resistance). For the affected batches, this means that the enteric-coated tablets behave similarly to immediate-release tablets. No complaints or side effects have been reported in this context, but a precautionary and voluntary recall is being carried out due to the deviations.

Name of the medicinal product 1. Diclofenac Sandoz 50 mg – Filmtabletten
2. DiclacHexal 50 mg – Filmtabletten
Marketing authorisation number(s) 1. 1-17996
2. 1-22495
Marketing authorisation holder 1. Sandoz GmbH
2. Hexal Pharma GmbH

Durchführung Rückruf:
Sandoz GmbH
Batch number(s) 1. DE4035, DS7444, EC1988, EF4836, DE4038, DS7437, EA7985, EN2014
2. BE5592, BK9539, BR1560, CY3356, DG7645, DN5652, DS8286, DR1944, ED4653, EN0404, BK9548, BR1576, CY3348, DG7650, DR0769, ED4657, EN0406
Classification of the recall2
BASG reference number INS - 640.001 - 1411

Further inquiry note