NaCl- und Glucoseinfusionslösungen
Recall
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Medicines
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26/04/2019
"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags. Therefore the marketing authorisation holder recalls below mentioned batches as a precautionary measure.
The medicinal product is authorised in Germany and is imported to Austria following the Medicinal Products Import Act.
| Name of the medicinal product | Infusionslösungen NaCl 0,9%: 250 ML, 500 ML, 1000 ML, 250/500 ML, 500/1000 ML Glucose 5%: 250 ML, 500 ML, 1000 ML, 250/500 ML |
|---|---|
| Marketing authorisation number(s) | NaCl 0,9%: Deutschland 1299.99.99; Glucose 5%: Deutschland 4999.99.99 |
| Marketing authorisation holder | Maco Pharma International GmbH Inverkehrbringerin in Österreich: MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH |
| Batch number(s) | • NaCl 0,9% 250 ML: 17F13A, 17H22B, 17K15B, 18A18C 18A19B,18A21A, 18C05C, 18C06D, 18E24B, 18F28A, 18G09A • NaCl 0,9% 500 ML: 18B05A, 18C07C • NaCl 0,9% 1000 ML: 17G04A, 18E18B • NaCl 0,9% 250/500 ML: 17G06A, 17J25B, 18B01A, 18B18A, 18E25A • NaCl 0,9% 500/1000 ML: 17G20D, 17J11B, 18F25A • Glucose 5% 250 ML: 18B15B • Glucose 5% 500 ML: 17L18H, 18F20A • Glucose 5% 1000 ML: 17I15B, 18E28A • Glucose 5% 250/500 ML: 17K06B, 18B13A |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-2851 |
Further inquiry note
Page last modified:
07/11/2019