FLUOXETIN Genericon Kapseln (20 mg und 40 mg), FLUOXETIN Genericon 20 mg Tabletten
Recall
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Medicines
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21/07/2023
The marketing authorisation holder informed its customers on July 20, 2023, that the nitrosamine quantities in the mentioned batches may be above the permitted acceptable daily dose. For this reason, all batches of „FLUOXETIN Genericon 20 mg Kapseln“, „FLUOXETIN Genericon 40 mg Kapseln“ and „FLUOXETIN Genericon 20 mg Tabletten“ that are within the shelf life are being recalled as a precautionary measure.
| Name of the medicinal product | 1. FLUOXETIN Genericon 20 mg Kapseln 2. FLUOXETIN Genericon 40 mg Kapseln 3. FLUOXETIN Genericon 20 mg Tabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-22540 2. 1-24476 3. 1-24028 |
| CIP code | 1. OP14: 1327536 1. OP30: 2442587 2. OP14: 2437712 2. OP30: 2437729 3. OP14: 2425761 3. OP30: 2446220 |
| Marketing authorisation holder | Genericon Pharma Ges.m.b.H. |
| Batch number(s) | Product / Pack size / Batch / Exp.date FLUOXETIN Genericon 20 mg Kapseln / OP14 / 2139A006 / 31.07.2025 FLUOXETIN Genericon 20 mg Kapseln / OP30 / 2139A008 / 31.07.2025 FLUOXETIN Genericon 40 mg Kapseln / OP30 / 2229A011 / 30.06.2025 FLUOXETIN Genericon 40 mg Kapseln / OP14 / 2045A027 / 31.10.2023 FLUOXETIN Genericon 40 mg Kapseln / OP30 / 2045A028 / 31.10.2023 FLUOXETIN Genericon 40 mg Kapseln / OP14 / 2137A005 / 31.07.2024 FLUOXETIN Genericon 40 mg Kapseln / OP30 / 2131A023 / 31.07.2024 FLUOXETIN Genericon 20 mg Tabletten / OP30 / 2228A052 / 28.02.2026 FLUOXETIN Genericon 20 mg Tabletten / OP14 / 2007A001 / 31.08.2023 FLUOXETIN Genericon 20 mg Tabletten / OP30 / 2007A006 / 31.07.2023 FLUOXETIN Genericon 20 mg Tabletten / OP14 / 2228A051 / 30.04.2026 FLUOXETIN Genericon 20 mg Tabletten / OP30 / 2228A053 / 30.04.2026 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-4341 |
Further inquiry note
Page last modified:
21/07/2023