Erypo
Recall
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Medicines
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28/05/2015
The marketing authorization holder has informed its supplied customers that a slightly increased level of oxidized methionine was found in stability tests after 12 months of storage. Methionine is part of the structure of erythropoietin, and oxidation of methionine in the formulation is a known, expected reaction and thus part of the testing and specification requirements. Due to the slightly elevated levels of oxidized methionine detected, it has now been decided to recall all affected batches.
| Name of the medicinal product | 1. ERYPO 1.000 I.E./0,5 ml – Fertigspritzen 2. ERYPO 2.000 I.E./0,5 ml – Fertigspritzen 3. ERYPO 4.000 I.E./0,4 ml – Fertigspritzen 4. ERYPO 10.000 I.E./ml – Fertigspritzen |
|---|---|
| Marketing authorisation number(s) | 1. 2-00130 2. 2-00131 3. 2-00133 4. 2-00134 |
| Marketing authorisation holder | Janssen- Cilag Pharma GmbH |
| Batch number(s) | 1. ECS1Q00, ECS1Q01 2. EAS1S00 3. EAS2X00, EBS5C00, EHS4F00 4. EKS5N00 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1412 |
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Page last modified:
12/07/2022