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 recall2
BASG reference number INS-640.001-0371
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