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FDA Import Refusal AEK-7582764-0/10002/1 — ACME Formulation Private Limited

ACME Formulation Private Limited — FEI 3016859498

The FDA refused shipment AEK-7582764-0/10002/1 from ACME Formulation Private Limited (India) on September 23, 2025. The refused product falls under Drugs and Biologics — OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 23, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
62KDE10 OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
Charges
75

Other import refusals

  • AEK-9448937-2/20003/1 (Sat Feb 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2209378-7/11/2 (Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-8578146-9/1/9 (Tue Aug 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-8733756-7/1/2 (Thu Aug 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-8774621-2/1/4 (Wed May 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources