Fenistil Ampoules

Recall | Medicines | 11/07/2013

The marketing authorization holder informed its supplied customers in a letter dated July 9, 2013, that in the course of quality assurance measures it was determined that in batch 1200758 isolated ampoules with yellowish discolored contents and thus a possible reduced active ingredient content were observed. Other batches of this product are not affected by this quality defect.

Name of the medicinal product Fenistil - Ampullen
Marketing authorisation number(s) 1-19861
Marketing authorisation holder Novartis Consumer Health - Gebro GmbH
Batch number(s) 1200758
Classification of the recall2
BASG reference number INS-640.001-0821

Further inquiry note