Home / Import refusals / 799-4455075-2/11/1

FDA Import Refusal 799-4455075-2/11/1 — Apotex, Inc.

Apotex, Inc. — FEI 3002808376

The FDA refused shipment 799-4455075-2/11/1 from Apotex, Inc. (Canada) on March 29, 2018. The refused product falls under Drugs and Biologics — RANITIDINE HYDROCHLORIDE (ANTACID). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 29, 2018
Country
Canada
Product Category
Drugs and Biologics
Product Code
60SIB25 RANITIDINE HYDROCHLORIDE (ANTACID)
Charges
118,75

Recent inspections

  • 1249246 (NAI Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230073 (NAI Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114893 (NAI Fri Nov 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100432 (VAI Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035875 (NAI Fri Dec 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-3885306-2/10002/1 (Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1232019-2/20003/1 (Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5212840-5/10003/1 (Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5212840-5/20003/1 (Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9760033-4/31/2 (Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources