Home/Recalls/FDA-D-0641-2026
FDA DrugsClass II

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units)...

Published: June 24, 2026Recall ID: D-0641-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations; deficiencies observed during FDA inspection

Product Description & Identification

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.

Additional Source Details

FieldValue
CityDadra And Nagar Haveli
Event id99137
Address 1225 - 4 - 1 Saily Village
Address 2Survey No
Code infoLot# 011, 014, 015, 016, 017, 018, 019, 020, 021, 022, 026, Within Expiry.
Postal codeN/A
Report date20260624
Product typeDrugs
Product quantity3006 tubes
Reason for recallCGMP Deviations; deficiencies observed during FDA inspection
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260602
Initial firm notificationE-Mail
Center classification date20260626

Overview

  • Recalling FirmDabur India Limited
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide.
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