Home / Import refusals / AEK-4994208-7/61/1

FDA Import Refusal AEK-4994208-7/61/1 — Emcure Pharmaceuticals Limited

Emcure Pharmaceuticals Limited — FEI 3005151215

The FDA refused shipment AEK-4994208-7/61/1 from Emcure Pharmaceuticals Limited (India) on April 12, 2024. The refused product falls under Drugs and Biologics — RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 12, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
60SCY27 RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER)
Charges
27

Recent inspections

  • 1079858 (OAI Wed Feb 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1075227 (NAI Tue Oct 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023101 (OAI Thu Aug 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912371 (OAI Wed Feb 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867389 (VAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-7180460-1/32/1 (Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-8379746-8/21/1 (Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8035262-6/21/1 (Thu Dec 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4765929-9/11/1 (Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4765929-9/11/2 (Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources