Drug Recall: QUARTET PAIN-RELEASING F.C. TABLETS Arthritis Pain Reliever (Nov 2020)

On November 24, 2020 (ROC year 109), the Food and Drug Administration of the Ministry of Health and Welfare of the Republic of China issued a “Class 2 Recall” drug recall notice regarding the arthritis pain reliever “QUARTET PAIN-RELEASING F.C. TABLETS 600MG” sold by Zhongfa Industrial Co., Ltd. The manufacturer voluntarily reported that the stability test results of the drug with the same active ingredient and packaging specification produced by the contract manufacturer did not meet the originally approved specifications, and after evaluation, the drug was voluntarily recalled.

The FDA reminds patients not to stop taking medication on their own arbitrarily, but to return to their physician as soon as possible to discuss prescribing other appropriate drugs. The manufacturer is required to complete the recall by December 16, 2020, and to submit a recall results report and subsequent preventive and corrective measures. At the same time, all medical institutions, pharmaceutical distributors, and pharmacies must cooperate with the recall and immediately stop dispensing and supplying the drug.

Basic Information on the Drug to Be Recalled

• Drug/Product Name: QUARTET PAIN-RELEASING F.C. TABLETS 600MG.
• Indications: Rheumatoid arthritis, osteoarthritis, relief of pain caused by musculoskeletal inflammation.
• Active Ingredient: IBUPROFEN.
• Drug License Number: Wei Shu Yao Zhi Zi No. 046866.
• Batch Numbers: QA-18001, QA-19001, QA-19002.
• License Holder: Zhongfa Industrial Co., Ltd. (Address: 6F, No. 782, Zhongzheng Rd., Zhonghe Dist., New Taipei City; Tel: 02-82217889).
• Main Manufacturer: Winston Medical Co., Ltd. (Address: No. 117, Ren’ai St., Yanzhou Vil., Yongkang Dist., Tainan City; Country: Republic of China)
• Reference photo of the drug:

Drug Recall Related Information

• Recall Classification[1]: 2.
• Recall Document Number: FDA Yao Zi No. 1090033493 dated November 17, 2020 (FDA Drug Division).
• Issuance Date: November 17, 2020.
• Publication Date: November 24, 2020.
• Reason for Recall: The manufacturer voluntarily reported that the stability test results of the drug with the same active ingredient and packaging specification produced by the contract manufacturer did not meet the originally approved specifications, so it was voluntarily and preventively recalled.

References

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