CHAMPIX 1 mg Filmtabletten and CHAMPIX 0,5 mg + 1 mg Filmtabletten
Recall
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Medicines
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27/09/2021
The marketing authorisation holder informed its customers on September 27, 2021, that all CHAMPIX batches that were found to contain levels of N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled.
| Name of the medicinal product | 1) CHAMPIX 1 mg Filmtabletten 2) CHAMPIX 0,5 mg + 1 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1) EU/1/06/360/021, EU/1/06/360/022 2) EU/1/06/360/023 |
| CIP code | 1) 3506533 (56 Stück), 3513680 (112 Stück) 2) 3525542 (53 Stück) |
| Marketing authorisation holder | Pfizer Europe MA EEIG |
| Distributor | Pfizer Corporation Austria Gesellschaft m.b.H. |
| Batch number(s) | 1) batches, expiry date (CIP code, pack size) 00019655, 30.11.2021 (PZN 3506533, 56 Stück) 00022647, 30.09.2022 (PZN 3506533, 56 Stück) EL6034, 28.02.2023 (PZN 3506533, 56 Stück) 00022811, 31.10.2022 (PZN 3513680, 112 Stück) 2) batches, expiry date (CIP code, pack size) 00023007, 31.10.2022 (PZN 3525542, 53 Stück) 00024077, 31.12.2022 (PZN 3525542, 53 Stück) |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3550 |
| Safety warnings Link | Safety information (DHPC): 211004_Champix.pdf |
Further inquiry note
Page last modified:
27/09/2021