Asthlax Tablets (Hwa Hsing Cough and Asthma Medication) | Drug Recall December 2020

The Food and Drug Administration of the Ministry of Health and Welfare of the Republic of China issued a “Class II Recall” drug recall announcement on December 4, 2020, regarding the cough and asthma medication “Asthlax Tablets “H.S."" sold by “Hwa Hsing Chemical Pharmaceutical Works Co., Ltd.” Following the manufacturer’s proactive report that the tablets of the batch in question had spots on their appearance, the drug was proactively requested for recall after evaluation.

The FDA reminds patients not to stop taking medication on their own arbitrarily, and to return for a consultation with their physician as soon as possible to prescribe other appropriate medications. It also requires the manufacturer to complete the recall operation before December 23, 2020, and to submit a recall results report and subsequent preventive and corrective measures. At the same time, all medical institutions, pharmaceutical firms, and pharmacies must cooperate with the recall operation and immediately stop dispensing and supplying.

Basic Information on the Drug to Be Recalled

• Drug/Product Name: Asthlax Tablets “H.S.”.
• Drug Indications: Cough from colds, pharyngitis, bronchitis, etc., hay fever, allergic asthma, bronchial asthma, pediatric asthma, cardiac asthma.
• Main Ingredients: CHLORPHENIRAMINE MALEATE, DL-METHYLEPHEDRINE HCL, PAPAVERINE HCL, DIPROPHYLLINE.
• Drug Permit Number: Wei Bu Yao Zhi Zi No. 058402.
• Batch Number: I201.
• Permit Holder: (1203612300) Hwa Hsing Chemical Pharmaceutical Works Co., Ltd. Address: No. 128, Siwei Lane, Tianwei Township, Changhua County, Taiwan, Republic of China;
• Contact Phone: 04-8832121.

Main Manufacturer: Same as above. Drug reference photo:

Drug Recall Related Information

• Recall Classification[1]: II.
• Recall Document Number: November 23, 2020, FDA Yao Zi No. 1090034192 (FDA Drug Division).
• Issuance Date: November 23, 2020.
• Publication Date: December 4, 2020.
• Reason for Recall: The manufacturer proactively reported that the tablets of the batch in question had spots on their appearance.

References

1. Introduction to the Ministry of Health and Welfare FDA’s “Drug Recall Classification System” and Handling Measures.