Cileste, TriCilest und Vivelle

Recall | Medicines | 04/06/2013

The marketing authorization holder informed its supplied customers in a letter dated June 3, 2013, that in the course of stability tests after 24 months of storage, non-specification-compliant results were found for a batch of Cileste in the dissolution test of Norgestimat. All other test parameters were within your specification. As TriCilest and Vivelle also contain the active ingredient norgestimate, batches of TriCilest and Vivelle are therefore being recalled as a precautionary measure in addition to Cileste. The product is being recalled at the level of the wholesalers and institutional pharmacies supplied.

Name of the medicinal product Cileste-Tabletten
TriCilest – Tabletten
Marketing authorisation number(s) Cileste-Tabletten: 1-18688
TriCilest – Tabletten: 1-20415
Vivelle-Tabletten: 1-22539
Marketing authorisation holder Janssen - Cilag Pharma GmbH
Batch number(s) Cileste-Tabletten:
BCS1Q00, BFS4Y00, BKS1X00, CCS1300, CFS3Z00, BCS1S00, BDS3Y00, BES1T00, BES3M00, BFS3C00, BKS0Z00, BKS1Y00, CBS0J00, CCS1400, CES2I00, CHS5G00, CIS0900, DAS3E00

TriCilest – Tabletten:
BHSK000, CBSK000,CGSK000, DASK000

BFSK000, CDSK000, CBSK000, CBSK001, CHSK000, DASK000
Classification of the recall3

Further inquiry note