Recall | Medicines | 05/09/2012

The parallel distributor, HAEMATO PHARM AG; has informed its supplied customers by letter dated 5.9.2012 that the batches placed on the market by him are recalled, because tablets were found which are light blue and have "GILEAD" as tablet embossing. However, the tablets approved for use in the EU are blue and embossed with "GILEAD" on one side and "701" on the other. The information should be passed on to the patients treated. Any tablets present in the patients should be returned to the outpatient clinics, hospitals, etc., and observations of changes in the color of the tablets or side effects should in any case be reported to the Federal Office for Safety in Health Care via the medical staff.

Name of the medicinal product Truvada 200 mg / 245 mg Filmtabletten
Marketing authorisation number(s) EU/1/04/305/001
Marketing authorisation holder Gilead Sciences International Limited, United Kingdom

Paralleldistribution und Durchführung Rückruf:
Batch number(s) DCNSD_200206, DCNSD_221404, DCNSD_223316
Classification of the recall1
BASG reference number INS-640.001-0530

Further inquiry note