奥地利 BASG 公告 Neuraxpharm 因溶出度超标预防性召回 Bupropion neuraxpharm 300 mg 缓释片

Bupropion neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung

AI 导读

Neuraxpharm Austria GmbH 于 2026 年 10 月 12 日通知客户，因溶出度检验结果超标，对 Bupropion neuraxpharm 300 mg 缓释片作预防性召回。

推荐理由

材料列出因溶出度超标而预防性召回的具体批次与效期，并标明召回等级和深度，便于核对受影响范围。

正文 · 原文

Recall | Medicines | 12/10/2026

The distributor informed its customers on October 12, 2026, that the mentioned batches are being recalled as a precautionary measure due to out of specification results for dissolution.

Name of the medicinal product	Bupropion neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Marketing authorisation number(s)	140370
CIP code	4987687, 4987693
Marketing authorisation holder	Neuraxpharm Arzneimittel GmbH
Distributor	Neuraxpharm Austria GmbH
Batch number(s)	Batch, Expiry Date 231701, 04/2027 231701-1, 04/2027 231702, 05/2027 N240794, 08/2027 231703, 10/2027
Classification of the recall	2
Depth of recall	Pharmacies
BASG reference number	INS-640.001-5887