FDA Import Refusal AEK-9687396-1/40002/1 — SUN PHARMACEUTICALS INDUSTRIES

SUN PHARMACEUTICALS INDUSTRIES — FEI 3012477999

The FDA refused shipment AEK-9687396-1/40002/1 from SUN PHARMACEUTICALS INDUSTRIES (India) on Aug 25, 2026. The refused product falls under Drugs and Biologics — KETOTIFEN FUMERATE (ANTI-ASTHMATIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Aug 25, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61ECY14 KETOTIFEN FUMERATE (ANTI-ASTHMATIC)
Charges
75

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