US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 7, 2018 (8 years ago)

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22

Recalling firm
US Pharmaceuticals Inc.
NDC code
53329-303-22
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0425-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.