Moderate riskFDA DrugClass II

Med Pride triple antibiotic ointment recalled for CGMP deviations

The FDA identified manufacturing deficiencies during inspection of Med Pride Triple Antibiotic Ointment (1oz tubes). Multiple lots do not meet required manufacturing standards. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your medicine cabinet for Med Pride Triple Antibiotic Ointment in 1oz tubes with lot numbers 001–035 (excluding 011, 014–022, 026, 030).
  2. Stop using the product if you have one of the affected lots.
  3. Contact Shield Line LLC or your pharmacy for instructions on return or disposal.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.
UPC code
  • 352410302558
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 14 products — see all of them.

Details

Units affected
8996 tubes
Illnesses reported
None reported
Manufactured in
225 - 4 - 1 Saily Village, Survey No, Dadra And Nagar Haveli, India
Classification
Class II
Recall number
D-0642-2026

In the FDA's words

Description
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8. CGMP Deviations; deficiencies observed during FDA inspection Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 023, 024, 025, 027, 028, 029, 031, 032, 033, 034, 035, Within Expiry. Distribution: US Nationwide. Affected quantity: 8996 tubes
Hazard
CGMP Deviations; deficiencies observed during FDA inspection

14 products in this recall

Med Pride, Lucky and more creams recalled for quality issues

Dabur is recalling 14 antibiotic and antifungal creams, ointments and first aid products, including Lucky Super Soft, Circle K, Lil Drug Store, Rapidol, Cura Hongos and Med Pride. The FDA found manufacturing quality problems (CGMP deviations) during an inspection. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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