Moderate riskFDA DrugClass II

Med Pride hydrocortisone cream recalled for manufacturing deviations

The FDA found manufacturing quality control problems (CGMP deviations) during an inspection of the facility that makes Med Pride Hydrocortisone Cream 1%. Multiple lots of the product are affected. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have Med Pride Hydrocortisone Cream 1% in the 16 oz tube size, particularly lots 003–064.
  2. Contact your pharmacy or healthcare provider if you have questions about whether your specific tube is affected.
  3. Do not use the product if you have one of the affected lots; return it to where you bought it or contact Shield Line LLC at the address on the package.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
UPC code
  • 352410305061
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 14 products — see all of them.

Details

Units affected
4,738 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-0639-2026

In the FDA's words

Description
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061. CGMP Deviations; deficiencies observed during FDA inspection Lot# 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 014, 015, 017, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 034, 035, 036, 037, 038, 039, 041, 042, 043, 044, 048, 049, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, Within Expiry. Distribution: US Nationwide. Affected quantity: 4,738 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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