Official announcements
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Medicines
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23/11/2017
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…
Recall
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Medicines
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08/11/2017
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…
Recall
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Medicines
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03/10/2017
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),…
Recall
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Medicines
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25/09/2017
"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…
Recall
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Medicines
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01/09/2017
"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…
Safety warnings
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Medicines
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11/08/2017
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.
Recall
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Medicines
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11/08/2017
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.
Recall
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Medicines
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11/08/2017
"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…
Recall
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Medicines
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27/07/2017
"Pascoe Pharm. Präparate GmbH" as the holder of the registration as a homeopathic medicinal speciality of "Quassia Similiaplex drops" has informed its supplied customers by letter dated 26.07.2017 that the registration will be cancelled as of…
Recall
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Medicines
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27/07/2017
The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2017, that a test result within the scope of a stability study showed a reduced active ingredient content. Therefore, the batch 559CG placed on the…