Anapen
Recall
|
Medicines
|
04/06/2012
The distribution company has informed its supplied customers in a letter dated 01.06.2012 that there is a potential problem with the dispensing time and dispensing volume after the autoinjector has been triggered. This problem has arisen during the development of a new variant which is not yet on the market. The potential risk is a possible reduced or delayed delivery of the epinephrine solution when used in an anaphylactic emergency. To date, there have been no confirmatory reports from patients or healthcare professionals in this regard.
| Name of the medicinal product | 1. Anapen 300 Mikrogramm in 0,3 ml - Injektionslösung (Fertigspritze) 2. Anapen Junior 150 Mikrogramm in 0,3 ml - Injektionslösung (Fertigspritze) |
|---|---|
| Marketing authorisation number(s) | 1. 1-25762 2. 1-25763 |
| Marketing authorisation holder | Lincoln Medical Ltd Vertrieb & Durchführung Rückruf: ROXALL Medizin GmbH |
| Batch number(s) | 1. RRT, TLB, VFN 2. RMV, TLA |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-0444 |
Further inquiry note
Page last modified:
12/07/2022