---
title: "Cipla 的美国分公司召回 400 多箱仿制抗癌药物：美国食品药品监督管理局（USFDA）"
type: "News"
locale: "zh-CN"
url: "https://longbridge.com/zh-CN/news/278249419.md"
description: "Cipla USA, Inc. 是 Cipla 的子公司，因生产问题正在召回超过 400 箱 Nilotinib 胶囊（150 毫克和 200 毫克），这一消息由美国食品药品监督管理局（USFDA）报告。该自愿召回属于 III 类，始于 2 月 18 日，表明接触该产品不太可能导致不良健康后果。Nilotinib 用于阻止癌细胞的增殖。印度制药公司在向美国市场供应药物方面发挥着重要作用，2022 年它们填补了相当大比例的处方"
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 的美国分公司召回 400 多箱仿制抗癌药物：美国食品药品监督管理局（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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