Ventolin Tablets 2mg for Bronchial and Asthma Use | Drug Recall Dec 2021

On December 28, 2021 (ROC year 110), the Food and Drug Administration of the Ministry of Health and Welfare of the Republic of China issued a “Class II Recall” drug recall notice regarding “Ventolin Tablets 2mg”, a medication for bronchial asthma, chronic bronchitis, and emphysema sold by “Synta Pharmaceutical Industry Co., Ltd.” The manufacturer voluntarily reported that the drug in the affected batch numbers may contain impurities derived from the active ingredient, so a preventive recall was initiated down to the wholesaler and distributor level.

The FDA has required the manufacturer to faithfully implement the proposed risk-reduction measures, and recommends expanding the scope of the recall to medical institutions, pharmacies, and drug dealers, while periodically confirming and reviewing the effectiveness of these measures to safeguard public medication safety.

Basic Information of the Drug to Be Recalled

• Drug/Product name: Ventolin Tablets 2mg
• Drug indication: Used for bronchial asthma, chronic bronchitis, and emphysema.
• Active ingredient: SALBUTAMOL SULFATE (ALBUTEROL SULFATE)
• Drug permit number: Wei Shu Yao Shu Zi No. 017536
• Batch numbers: B00021C, B75420KA, B75420K, B61820H
• Permit holder: GlaxoSmithKline Taiwan Branch.

Address: 24F, No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist., Taipei City 100, Taiwan, Republic of China.

• Contact phone: +886-2-2381-8866

Main manufacturer: Aspen Bad Oldesloe GmbH

Manufacturer address: INDUSTRIESTRASSE 32-36, 23843 BAD OLDESLOE GERMANY

Reference photo of the drug:

Ventolin Tablets 2mg

Drug Recall Information

• Recall classification[1]:
• Recall document number: December 28, 2021 (ROC year 110) FDA Yao Zi No. 1106034890 (FDA Drug Division).
• Issue date: December 28, 2021 (ROC year 110).
• Publication date: December 28, 2021 (ROC year 110).
• Reason for recall: The manufacturer voluntarily reported that the drug in the affected batch numbers may contain impurities derived from the active ingredient, so a preventive recall was initiated down to the wholesaler and distributor level.

References

1. Introduction to the “Drug Recall Classification System” and Handling Measures by the FDA, Ministry of Health and Welfare.
2. Western medicine, medical device, and cosmetics permit inquiry