The marketing authorization holder informed its supplied customers in a letter dated 27.11.2017 that the stability test did not comply with the test for gastric juice resistance. The potential impact on patient safety is assessed as low. All other batches available in Austria are not affected by this recall.

The distribution partner for the marketing authorization holder, "DSD Pharma GmbH", informed its supplied customers in a letter dated November 15, 2017, that the qualified person for batch 171115FDG01 has not issued a batch release and that the batch in question may therefore not be used.

The marketing authorization holder has informed its supplied customers in a letter dated 22.11.2017 that deviations from the microbial limit values were detected in a batch marketed abroad. As a precautionary measure, all batches that were produced within a short time of this are now being recalled. In Austria, this concerns batch T12052 of the…

The marketing authorization holder informed its supplied customers in a letter dated November 8, 2017, that a production-related crack at the valve connection seal to the bag may occur in "Physioneal Clear-Flex bags". On the one hand, the crack could result in possible microbiological contamination of the solution, and on the other hand, this…

In a letter dated September 27, 2017, the marketing authorization holder informed its customers that an incorrect expiration date was printed on batch 7103 of "Coldan Nasal Spray". The expiration date was printed incorrectly as "2022-06" (June 2022), the correct date is "2020-06" (June 2020).

"ALK -Abelló Allergie -Service GmbH "has informed its supplied customers in a letter dated 21.09.2017 that bottles of "Pangramin Prick Rye Flour" with brown colored and cloudy solutions have been detected. These solutions can lead to false negative reactions due to a possibly lower allergen content, so that the two batches are recalled as a…

"AOP Orphan Pharmaceuticals AG" informed its supplied customers by letter dated August 31, 2017, that "Thromboreductin 1.0 mg Capsules" was placed on the market as a medicinal product not authorized in Austria in this strength with defective packaging, since the labeling and directions for use were not approved by the BASG.

The drug "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" is being recalled due to suspected drug counterfeiting.

The marketing authorization holder has informed its supplied customers in a letter dated August 10, 2017, that a batch of Vibravenous - Ampoules with batch number B113306 is being recalled due to distinct color changes.

"Koanaa Healthcare GmbH" has informed its customers in a letter dated August 10, 2017, that the further marketing of "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" will be stopped and a recall will be carried out.On the part of the Federal Office for Safety in Health Care (BASG), there is an…