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FDA Import Refusal AEK-9455094-2/10003/1 — Lupin LTD.

Lupin LTD. — FEI 3012538759

The FDA refused shipment AEK-9455094-2/10003/1 from Lupin LTD. (India) on March 3, 2026. The refused product falls under Drugs and Biologics — AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 3, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61XDK50 AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
Charges
118,75

Other import refusals

  • AEK-0265576-8/10002/1 (Tue May 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0113241-3/10002/1 (Mon Mar 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9432979-2/50003/1 (Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9088021-0/10003/1 (Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1092242-9/10003/1 (Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources