Helixate NexGen
Recall
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Medicines
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14/10/2016
CSL Behring as distributor of the product Helixate NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers in a letter dated October 11, 2016, that the above mentioned batches of Helixate NexGen are being recalled. Stability data for these batches indicated a faster than usual decline in potency.
Since there is no assurance that the active ingredient content will remain within specification until the expiration date, these batches are being recalled.
| Name of the medicinal product | 1. Helixate NexGen 250 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung 2. Helixate NexGen 500 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung 3. Helixate NexGen 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung 4. Helixate NexGen 2000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
|---|---|
| Marketing authorisation number(s) | 1. EU/1/00/144/001 2. EU/1/00/144/002 3. EU/1/00/144/003 4. EU/1/00/144/004 |
| Marketing authorisation holder | Bayer Pharma AG |
| Batch number(s) | 1. 270R0LTG 2. 270P411C, 270P8V5T, 270PCP4G 3. 270P9CLB, 270R1C6M, 270TN0RJ 4. 270R0NPL, 270R53HE, 270TGK3A |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-1858 |
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Page last modified:
12/07/2022