Home / Import refusals / 799-5212840-5/10003/1

FDA Import Refusal 799-5212840-5/10003/1 — Apotex Inc.

Apotex Inc. — FEI 3002906944

The FDA refused shipment 799-5212840-5/10003/1 from Apotex Inc. (Canada) on October 20, 2025. The refused product falls under Drugs and Biologics — FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 20, 2025
Country
Canada
Product Category
Drugs and Biologics
Product Code
61NDA66 FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
Charges
75

Recent inspections

  • 1269753 (NAI Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1187415 (NAI Fri Sep 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096465 (NAI Wed Jun 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055197 (NAI Thu May 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014399 (VAI Wed Jun 14 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)
  • 799-5212840-5/20003/1 (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)
  • AEK-5679307-6/21/1 (Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources