FDA Import Refusal 799-3278503-6/20003/1 — SANOFI MEDLEY FARMACEUTICA LTDA

SANOFI MEDLEY FARMACEUTICA LTDA — FEI 3016754729

The FDA refused shipment 799-3278503-6/20003/1 from SANOFI MEDLEY FARMACEUTICA LTDA (Brazil) on Jan 6, 2026. The refused product falls under Drugs and Biologics — FEXOFENADINE HCL (ANTI-ASTHMATIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal details

Date
Jan 6, 2026
Country
Brazil
Product Category
Drugs and Biologics
Product Code
61ECL06 FEXOFENADINE HCL (ANTI-ASTHMATIC)
Charges
75

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