Ephedrine Streuli and Vitamin A Streuli
During a routine test, leaks in the area of the predetermined breaking point at the neck of an amber glass ampoule of the size 1 ml were discovered in a product batch that has not yet been released, which are due to a material defect in the glass. Therefore, the marketing authorization holder recalls various injection solutions.
The affected products of Streuli Pharma AG are not approved in Austria. Based on the notifications for the import of medicinal products at the BASG/AGES, only the two products listed above should have been imported into Austria.
Further details on the recall and a list of all products affected by the recall can be found on the Swissmedic website at
http://www.swissmedic.ch or http://www.swissmedic.ch/marktueberwachung/00091/00118/02386/index.html?lang=de
| Name of the medicinal product | 1. Ephedrin Streuli Injektionslösung 2. Vitamin A Streuli Injektionslösung |
|---|---|
| Marketing authorisation number(s) | 1. CH-Zulassungsnummer: 52‘118 2. CH-Zulassungsnummer: 34‘210 |
| Marketing authorisation holder | Streuli Pharma AG, Schweiz |
| Batch number(s) | 1. 1270017, 1270077 2. 1270078 |
| Classification of the recall | 1 |
| BASG reference number | INS-640.001-0761 |
