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Dear Doctor Letter (Rote-Hand-Brief) on Fenistil® 1 mg/ml solution for injection (dimethindene maleate): Quality defects; recall of two batches

2014.11.25

Active substance: dimethindene maleate

The company Novartis Consumer Health GmbH is sending out information on the recall of batches 11027154 and 11045012 of the medicinal product Fenistil® 1 mg/ml solution for injection as the vials of both batches partially exhibit leakage at the break point of the snap-off ampoules. The solution escapes to a slight degree at this point and crystallises.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 483KB, File is accessible