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FDA Import Refusal AEK-7950533-3/20003/1 — Alkem Health Science

Alkem Health Science — FEI 3012147269

The FDA refused shipment AEK-7950533-3/20003/1 from Alkem Health Science (India) on December 18, 2025. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 18, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
56BDA03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
75

Other import refusals

  • 1FX-5554870-4/30002/2 (Thu May 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-5554870-4/40002/1 (Thu May 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9441337-2/10003/1 (Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9222157-9/30003/1 (Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9186485-8/160003/1 (Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources