The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that the translucent white cap on the tip of the BUCCOLAM application syringe can get stuck. This creates the possibility that administration may be…

The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that complaints about loose or rotating metal caps have been received. Therefore, the affected batches are recalled from the market as a precaution.

The marketing authorization holder informed its supplied customers in a letter dated January 23, 2018, that "Saroten 10mg Film-Coated Tablets" was placed on the market with an incorrect dosage information for the treatment of depressive disorders…

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…

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…

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…

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…

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),…

"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…

"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…