Reported Feb 13, 2019 · Terminated

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline…

US Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: US Pharmaceuticals Inc. · 681 Main St Ste 27 · Belleville, NJ · 07109-3471

Is this the product you have?

  • Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes
  • Manufactured in USA forMedline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
Lot codes and dates
    • Lot #: 50G17
    • Exp. 5/2019
    • 76J17
    • Exp. 7/2019
Amount recalled
19752 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 6, 2023 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.