Various medicinal products from B. Braun Melsungen AG
Recall
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Medicines
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02/08/2023
The marketing authorisation holder informed its customers on August 01, 2023 that contamination with traces of midazolam is possible in the listed batches of the mentioned infusion solutions. For this reason, these batches are recalled as a precautionary measure.
*The medicinal product is authorised in Germany and placed on the market in Austria under the Austrian Act on the Import of Medicinal Products.
| Name of the medicinal product | 1. Amikacin B. Braun 2,5 mg/ml Infusionslösung 2. Amikacin B. Braun 5 mg/ml Infusionslösung 3. Fluconazol B. Braun 2 mg/ml Infusionslösung 4. Gentamicin B. Braun 1 mg/ml Infusionslösung 5. Gentamicin B. Braun 3 mg/ml Infusionslösung 6. Ibuprofen B. Braun 400 mg Infusionslösung 7. Ibuprofen B. Braun 600 mg Infusionslösung 8. Paracetamol B. Braun 10 mg/ml Infusionslösung 9. Tobramycin B. Braun 1 mg/ml Infusionslösung 10. Aqua ad injectionem B. Braun Lösungsmittel zur Herstellung von Parenteralia 11. Isotone Kochsalzlösung 0,9 % Braun* |
|---|---|
| Marketing authorisation number(s) | 1. 1-30968 2. 1-30969 3. 1-28430 4. 1-28365 5. 1-28367 6. 138239 7. 138240 8. 1-31280 9. 1-29023 10. 1-18468 11. N/A* |
| CIP code | 1. 4204946 2. 4204952 3. 3775641, 3775658 4. 3902660 5. 3902677 6. 4956445 7. 4956451 8. 3921812 9. 3777812 10. 1766230 11. 3287628 |
| Marketing authorisation holder | B. Braun Melsungen AG, Melsungen, DE |
| Batch number(s) | 1. Batch, Expiry Date 21065403, 31.01.2024 21265401, 30.06.2024 2. Batch, Expiry Date 21066402, 31.01.2024 22131402, 28.02.2024 22243412, 31.05.2024 3. Batch, Expiry Date 21511402, 30.11.2023 21425404, 30.09.2023 21426401, 30.09.2023 21475402, 31.10.2023 22094403, 29.02.2024 4. Batch, Expiry Date 22166411, 31.03.2025 5. Batch, Expiry Date 22037416, 31.12.2024 6. Batch, Expiry Date 20511404, 30.11.2023 20512401, 30.11.2023 21145402, 31.03.2024 21265404, 30.06.2024 21355401, 31.08.2024 21387413, 31.08.2024 22095403, 28.02.2025 22133406, 28.02.2025 7. Batch, Expiry Date 20511406, 30.11.2023 20511407, 30.11.2023 21016409, 31.12.2023 21096411, 29.02.2024 21184409, 30.04.2024 21206403, 30.04.2024 22037415, 31.12.2024 22096403, 28.02.2025 22135411, 31.03.2025 22136410, 31.03.2025 22173401, 31.03.2025 8. Batch, Expiry Date 21385408, 31.08.2023 21386408, 31.08.2023 21421404, 30.09.2023 21422413, 30.09.2023 21506405, 30.11.2023 21506406, 30.11.2023 9. Batch, Expiry Date 21261405, 31.05.2024 10. Batch, Expiry Date 21144401, 31.03.2024 11. Batch, Expiry Date 20394402, 31.08.2023 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-4416 |
Further inquiry note
Page last modified:
02/08/2023