Recall | Medicines | 24/11/2014

The distributor has informed its supplied customers in a letter dated 19.11.2014 that there is a possibility of crystallization (particle formation) in the injection solution of the above batch. The crystals observed are probably precipitated progesterone. The recall leads to a temporary restriction of distribution.

Name of the medicinal product Progedex 25 mg Injektionslösung
Marketing authorisation number(s) 1-31810
Marketing authorisation holder IBSA Farmaceutici Italia Srl

Vertrieb & Durchführung Rückruf:
Astro Pharma GmbH
Batch number(s) 140572
Classification of the recall2
BASG reference number INS - 640.001 - 1261

Further inquiry note