Tadalafil Aristo 5 mg/10 mg/20 mg Filmtabletten
Recall
|
Medicines
|
11/07/2022
The marketing authorisation holder informed its customers on July 08, 2022, that serious deficiencies in good manufacturing practice were found during an inspection of the contract manufacturer in Turkey by the Belgian health authority. As it cannot be ruled out with certainty that the product contains impurities, the batches mentioned are being recalled as a precaution.
| Name of the medicinal product | 1) Tadalafil Aristo 5 mg Filmtabletten 2) Tadalafil Aristo 10 mg Filmtabletten 3) Tadalafil Aristo 20 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1) 137782 2) 137780 3) 137781 |
| CIP code | 1) 4980811, 4980828, 4980834 2) 4471104, 4471110, 4471127 3) 4471133, 4471156, 4471162, 4471179 |
| Marketing authorisation holder | Aristo Pharma GmbH |
| Batch number(s) | 1) Batch, Expiry Date 0464020E, 11/2022 0464020D, 11/2022 0464020C, 11/2022 1464006KA, 08/2024 1464006JA, 08/2024 1464006GA, 08/2024 1464010C, 11/2024 2) Batch, Expiry Date 0463002D, 06/2022 0463002G, 06/2022 0463004G, 09/2022 0463003C, 09/2022 1463002C, 02/2023 1463003J, 09/2024 1463003H, 09/2024 1463003HA, 09/2024 1463005C, 11/2024 3) Batch, Expiry Date 0462018C, 06/2022 0462027D, 08/2022 1462016H, 09/2022 0462019C, 08/2024 1462005F, 04/2023 1462021L, 11/2024 1462022D, 12/2024 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3931 |
Further inquiry note
Page last modified:
11/07/2022