Flux Hexal 20 mg – Kapseln and Fluoxetin 1A Pharma 20 mg – Kapseln

Recall | Medicines | 20/02/2024

The marketing authorisation holders informed its customers on February 19, 2024, that the nitrosamine quantities in the batches mentioned may be  above the permitted acceptable daily dose. For this reason, these batches are being recalled as a precautionary measure.

Name of the medicinal product 1) Flux Hexal 20 mg – Kapseln
2) Fluoxetin 1A Pharma 20 mg – Kapseln
Marketing authorisation number(s) 1) 1-23003
2) 1-24567
CIP code 1) 1332224, 2461550
2) 2438752, 2461567
Marketing authorisation holder 1) Hexal Pharma GmbH
2) 1A Pharma GmbH
Batch number(s) 1) Batch, Expiry Date
KZ9508, 07/2025

2) Batch, Expiry Date
KU9020, 05/2025
LL1183, 07/2025
LL0432, 07/2025
Classification of the recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-4517
Email

Further inquiry note