SYMITEC F.C. Tablets (Rhinitis and Allergy Medication) — Drug Recall, December 2020

On December 4, 2020 (ROC year 109), the Food and Drug Administration of Taiwan’s Ministry of Health and Welfare issued a Class 2 drug recall notice for ‘SYMITEC F.C. TABLETS 10MG,’ a rhinitis and allergy medication sold by S.D. Pharmaceutical Co., Ltd. The manufacturer voluntarily reported that during the 24-month stability testing of the batch in aluminum foil packaging, related degradation substances exceeded the originally approved specifications, and the product was voluntarily recalled after evaluation.

The FDA reminds patients not to stop taking medication on their own and to return to their physician promptly to discuss alternative prescriptions. The manufacturer was required to complete the recall by December 27, 2020, and to submit a recall report along with follow-up corrective and preventive measures. Meanwhile, all medical institutions, pharmaceutical distributors, and pharmacies must cooperate with the recall and immediately stop dispensing and supplying the product.

Basic Information on the Drug to Be Recalled

• Product name: ‘S.D.’ SYMITEC F.C. TABLETS 10MG.
• Indications: Seasonal rhinitis, conjunctivitis, allergic rhinitis, urticaria, allergic pruritus, and other allergic conditions.
• Active ingredient: CETIRIZINE DIHYDROCHLORIDE (EQ TO CETIRIZINE 2HCL).
• Drug license number: Wei Bu Yao Zhi Zi No. 043818.
• Batch numbers: 07126, 01057, 03097, 04117.
• License holder: (0507809200) S.D. Pharmaceutical Co., Ltd. Address: No. 2, 15th Road, Xitun Industrial Zone, Taichung City, Taiwan, ROC.
• Contact phone: 04-2359-3862.

Main manufacturer: Same as above. Reference photo of the drug:

Drug Recall Related Information

• Recall classification[1]: 2.
• Recall document number: FDA Yao Zi No. 1090034191, dated November 27, 2020 (FDA Drug Division).
• Issue date: November 27, 2020.
• Announcement date: December 4, 2020.
• Reason for recall: The manufacturer voluntarily reported that during the 24-month stability testing of the batch in aluminum foil packaging, related degradation substances exceeded the originally approved specifications.

References

1. Introduction to and handling procedures of the Ministry of Health and Welfare FDA’s ‘Drug Recall Classification System.’
2. Query of licenses for Western medicines, medical devices, and cosmetics.