# China NMPA Product Recall - Paroxetine hydrochloride tablets (20mg), paroxetine hydrochloride enteric-coated extended-release tablets (12.5mg), paroxetine hydrochloride enteric-coated extended-release tablets (25mg)

Source: https://www.globalkeysolutions.net/records/china_product_recall/glaxosmithkline-tianjin-pharmaceutical-co-ltd-glaxosmithkline-inc-canada/4c8dc997-da3b-412d-9ed9-543fc98ae7d6/
Source feed: China

> China NMPA product recall for Paroxetine hydrochloride tablets (20mg), paroxetine hydrochloride enteric-coated extended-release tablets (12.5mg), paroxetine hydrochloride enteric-coated extended-release tablets (25mg) by GlaxoSmithKline (Tianjin) Pharmaceutical Co., Ltd., GlaxoSmithKline Inc. (Canada) published May 13, 2014. Recall level: Level 3 Recall. GlaxoSmithKline (GSK) initiated a voluntary global recall of specific batches of paroxetine hydrochl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GlaxoSmithKline voluntarily recalls specific batches of paroxetine hydrochloride formulations.
- Company Name: GlaxoSmithKline (Tianjin) Pharmaceutical Co., Ltd., GlaxoSmithKline Inc. (Canada)
- Publication Date: 2014-05-13
- Product Name: Paroxetine hydrochloride tablets (20mg), paroxetine hydrochloride enteric-coated extended-release tablets (12.5mg), paroxetine hydrochloride enteric-coated extended-release tablets (25mg)
- Recall Level: Level 3 Recall
- Recall Reason: During an inspection of GlaxoSmithKline's Cork County, Ireland plant, the FDA expressed concerns about the plant releasing a specific batch of contaminated active pharmaceutical ingredients.
- Discovering Company: GlaxoSmithKline (China) Investment Co., Ltd.
- Manufacturing Company: GlaxoSmithKline (Tianjin) Pharmaceutical Co., Ltd., GlaxoSmithKline Inc. (Canada)
- Summary: GlaxoSmithKline (GSK) initiated a voluntary global recall of specific batches of paroxetine hydrochloride tablets and extended-release tablets following an October 2013 U.S. Food and Drug Administration (FDA) inspection of its Corkshire, Ireland plant. The FDA's warning letter raised concerns about the release of contaminated active pharmaceutical ingredients from the facility. Despite GSK's assessment indicating an extremely low safety risk to patients, the company committed to the recall. In China, the National Medical Products Administration (NMPA), formerly CFDA, mandated GSK (China) Investment Co., Ltd. to conduct the recall concurrently with international operations, adhering to China's "Drug Recall Management Measures." The recall involved various batches of 20mg tablets and 12.5mg/25mg extended-release tablets. GSK established an implementation team, notified Chinese regulatory bodies, and instructed distributors to halt distribution. The company is required to complete the recall by May, with all affected products to be destroyed under regulatory supervision. This action underscores GSK's commitment to corporate responsibility and product quality assurance.

Company: https://www.globalkeysolutions.net/companies/glaxosmithkline-tianjin-pharmaceutical-co-ltd-glaxosmithkline-inc-canada/3d32f4b2-78ab-4010-ba97-cf6c50a74ba1/