Cileste, TriCilest und Vivelle
Recall
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Medicines
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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 Vivelle-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 Vivelle-Tabletten: BFSK000, CDSK000, CBSK000, CBSK001, CHSK000, DASK000 |
| Classification of the recall | 3 |
Further inquiry note
Page last modified:
12/07/2022