Home/Recalls/FDA-D-0633-2026
FDA DrugsClass II

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomyc...

Published: June 24, 2026Recall ID: D-0633-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations; deficiencies observed during FDA inspection

Product Description & Identification

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.

Additional Source Details

FieldValue
CityDadra And Nagar Haveli
Event id99137
Address 1225 - 4 - 1 Saily Village
Address 2Survey No
Code infoLot# 0004, within expiry
Postal codeN/A
Report date20260624
Product typeDrugs
Product quantity84 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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