Gastrografin
Recall
|
Medicines
|
09/03/2012
The marketing authorization holder has informed its supplied customers in a letter dated March 2, 2012, that the packages of the batches listed above contain a non-updated package insert. Since e.g. changes of the side effect profile as well as a new indication for use are missing, the affected batches will be recalled from the market.
Name of the medicinal product | Gastrografin - Röntgenkontrastmittel zur oralen und rektalen Anwendung |
---|---|
Marketing authorisation number(s) | 11.920 |
Marketing authorisation holder | Bayer Austria GmbH |
Batch number(s) | MA006KC, MA0046H, 04104A, 03097A, 01074B |
Expiry date | 09/04/2019 |
Classification of the recall | 2 |
BASG reference number | INS-640.001-0371 |
Further inquiry note
Page last modified:
12/07/2022