FDA Import Refusal AEK-7471871-7/10002/1 — HANMI PHARM. CO., LTD.

HANMI PHARM. CO., LTD. — FEI 3003040331

The FDA refused shipment AEK-7471871-7/10002/1 from HANMI PHARM. CO., LTD. (South Korea) on Aug 22, 2025. The refused product falls under Drugs and Biologics — ISOTRETINOIN (KERATOLYTIC). Cited charge: 75 This firm has 1 other import refusal on record.

Refusal details

Date
Aug 22, 2025
Country
South Korea
Product Category
Drugs and Biologics
Product Code
64XDY11 ISOTRETINOIN (KERATOLYTIC)
Charges
75

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.