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Moderate riskFDA DrugClass II

Circle K triple antibiotic ointment recalled for CGMP deviations

Circle K triple antibiotic ointment tubes manufactured by Dabur India Limited have been recalled due to deficiencies found during an FDA inspection. The affected lots (0001 and 0005) do not meet current manufacturing standards for sterile products.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your medicine cabinet for Circle K triple antibiotic ointment in 0.5 oz tubes with lot number 0001 or 0005
  2. Stop using the product if you have it
  3. Dispose of it safely or return it to the retailer where you purchased it
  4. Contact your doctor or pharmacist if you have questions about alternatives
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.
UPC codes
  • 1942836518100
  • 194283651810
Sold in
Nationwide
Made for
All ages

This recall covers 14 products — see all of them.

Details

Units affected
2420 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-0631-2026

In the FDA's words

Description
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0. CGMP Deviations; deficiencies observed during FDA inspection Lot# 0001, and Lot# 0005, within expiry Distribution: US Nationwide. Affected quantity: 2420 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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