Home/Recalls/FDA-D-0637-2026
FDA DrugsClass II

Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Ma...

Published: June 24, 2026Recall ID: D-0637-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations; deficiencies observed during FDA inspection

Product Description & Identification

Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.

Additional Source Details

FieldValue
CityDadra And Nagar Haveli
Event id99137
Address 1225 - 4 - 1 Saily Village
Address 2Survey No
Code infoLot# 022, 023 ,024, Within Expiry.
Postal codeN/A
Report date20260624
Product typeDrugs
Product quantity1185 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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