---
title: "Cipla 的美國分公司召回 400 多箱仿製抗癌藥物：美國食品藥品監督管理局（USFDA）"
type: "News"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/278249419.md"
description: "Cipla USA, Inc. 是 Cipla 的子公司，因生產問題正在召回超過 400 箱 Nilotinib 膠囊（150 毫克和 200 毫克），這一消息由美國食品藥品監督管理局（USFDA）報告。該自願召回屬於 III 類，始於 2 月 18 日，表明接觸該產品不太可能導致不良健康後果。Nilotinib 用於阻止癌細胞的增殖。印度製藥公司在向美國市場供應藥物方面發揮着重要作用，2022 年它們填補了相當大比例的處方"
datetime: "2026-03-08T05:34:43.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/278249419.md)
  - [en](https://longbridge.com/en/news/278249419.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/278249419.md)
---

# Cipla 的美國分公司召回 400 多箱仿製抗癌藥物：美國食品藥品監督管理局（USFDA）

A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).

Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report.

The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated.

Cipla USA, Inc initiated the Class III voluntary recall on February 18 this year.

According to the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

 

Nilotinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.

Indian pharmaceutical companies supply a substantial proportion of drugs to US residents, with four out of 10 of all prescriptions filled in the US in 2022 being supplied by Indian companies.

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