Home / Import refusals / B8P-0191185-2/21/1

FDA Import Refusal B8P-0191185-2/21/1 — Mylan Laboratories Limited

Mylan Laboratories Limited — FEI 3005587313

The FDA refused shipment B8P-0191185-2/21/1 from Mylan Laboratories Limited (India) on April 29, 2022. The refused product falls under Drugs and Biologics — DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 29, 2022
Country
India
Product Category
Drugs and Biologics
Product Code
62OCB24 DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
Charges
118,75

Recent inspections

  • 1117137 (NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076887 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050962 (VAI Thu Apr 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986244 (OAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920472 (VAI Wed Mar 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-9307357-3/10003/1 (Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-9867116-1/11/1 (Tue Apr 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-0304813-3/11/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8160423-1/21/1 (Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5060456-2/11/1 (Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources