Progedex
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 recall | 2 |
| BASG reference number | INS - 640.001 - 1261 |
Further inquiry note
Page last modified:
12/07/2022