FDA Import Refusal 799-5133554-8/50002/1 — HETERO

HETERO — FEI 3014802596

The FDA refused shipment 799-5133554-8/50002/1 from HETERO (Colombia) on Nov 25, 2025. The refused product falls under Drugs and Biologics — QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II). Cited charge: 75 This firm has 1 other import refusal on record.

Refusal details

Date
Nov 25, 2025
Country
Colombia
Product Category
Drugs and Biologics
Product Code
66NDA03 QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
Charges
75

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