Orient Pharma Co., Ltd. Yunlin Plant

FDA Regulatory Profile

Orient Pharma Co., Ltd. Yunlin Plant appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0527-2025, Class III) was initiated on June 11, 2025.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0527-2025Class IIIPitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1sJune 11, 2025
D-0526-2025Class IIIPitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1sJune 11, 2025