Home / Import refusals / AEK-9456243-4/70003/1

FDA Import Refusal AEK-9456243-4/70003/1 — ALKEM LABORATORIES LTD

ALKEM LABORATORIES LTD — FEI 3012956161

The FDA refused shipment AEK-9456243-4/70003/1 from ALKEM LABORATORIES LTD (India) on April 8, 2026. The refused product falls under Drugs and Biologics — ONDANSETRON HYDROCHLORIDE (ANTI-EMETIC/NAUSEANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 8, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61TDY28 ONDANSETRON HYDROCHLORIDE (ANTI-EMETIC/NAUSEANT)
Charges
75

Other import refusals

  • 1FX-4357427-6/10002/3 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-3180072-4/20002/2 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-3172505-3/10002/1 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9281602-2/110003/1 (Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • AEK-9441345-5/40003/1 (Mon Feb 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources