"Hong Wen" Apa-Cymba Capsules for Anxiety and Neuralgia | Drug Recall 112.05

The Food and Drug Administration of the Ministry of Health and Welfare of the Republic of China issued a “Recall Classification Level 2” drug recall announcement on May 30, 112th Year of the Republic of China, regarding “Hong Wen” Apa-Cymba Capsules 30mg sold by “Hong Wen Pharmaceutical Industrial Co., Ltd.” for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.

This time, because the dissolution test results of some batches of the drug during stability testing did not meet specifications, dissolving more than the specified 10% in the gastric acid environment and affecting intestinal absorption of the drug’s efficacy, the manufacturer voluntarily reported and initiated a recall.

The FDA has required the manufacturer to complete the recall operation before June 16, 112th Year of the Republic of China and to submit a recall results report and follow-up preventive and corrective measures.

Basic Information of the Drug to Be Recalled

• Drug/Product name: “Hong Wen” Apa-Cymba Capsules 30mg
• Drug indication: Used for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.
• Active ingredient: duloxetine hydrochloride
• Drug permit license number: Wei Bu Yao Zhi Zi No. 059274
• Batch numbers: BAT022, BBU103, BBW141, BAU076, BBO005, BBM085, BBS024, BAS006, BAS007, BBM086, BBO006, BBU104, BAT023, BAU077, BAQ071, BBW140, BAQ070, BBS025, 18 batches in total.
• License holder: Hong Wen Pharmaceutical Industrial Co., Ltd.
• Main manufacturer:
• Manufacturing plant address:
• Drug reference:

“Hong Wen” Apa-Cymba Capsules 30mg

Drug Recall Related Information

• Recall classification[1]: Level 2
• Recall document number: May 17, 112th Year of the Republic of China FDA Yao Zi No. 1121405137 (FDA Drug Division)
• Release date: May 30, 112th Year of the Republic of China.
• Issuance date: May 17, 112th Year of the Republic of China.
• Recall reason: The manufacturer voluntarily reported that the dissolution test results of some batches of the drug during stability testing did not meet specifications, so a recall was initiated.

References

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