Moderate riskFDA DrugClass II

Med Pride bacitracin zinc ointment recalled for CGMP deviations

The FDA found manufacturing quality control problems during an inspection of the facility that produced Med Pride Bacitracin Zinc Ointment. This ointment is used to help prevent infection in minor cuts and scrapes. The affected batches were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have Med Pride Bacitracin Zinc Ointment 1 oz tubes with lot numbers 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, or 020.
  2. Stop using the product if you have an affected lot.
  3. Consult your doctor or pharmacist about alternative wound care products.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
UPC codes
  • 3524103035480
  • 352410303548
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 14 products — see all of them.

Details

Units affected
4374 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-0636-2026

In the FDA's words

Description
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8. CGMP Deviations; deficiencies observed during FDA inspection Lot# 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, 020, Within Expiry. Distribution: US Nationwide. Affected quantity: 4374 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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