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FDA Import Refusal 9L7-1236564-7/21/1 — Kenvue Canada Inc.

Kenvue Canada Inc. — FEI 1000328785

The FDA refused shipment 9L7-1236564-7/21/1 from Kenvue Canada Inc. (Canada) on May 24, 2024. The refused product falls under Drugs and Biologics — LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL). Cited charges: 118,118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 24, 2024
Country
Canada
Product Category
Drugs and Biologics
Product Code
62KAE08 LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
Charges
118,118

Recent inspections

  • 1265789 (VAI Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039074 (NAI Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 680233 (VAI Fri Jul 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-9737044-5/60003/1 (Thu May 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9L7-1244750-2/21/1 (Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9L7-1236564-7/51/1 (Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9L7-1236564-7/61/1 (Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-8871919-2/11/1 (Thu Jan 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources