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

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a)…

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

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.

Recalling firm
US Pharmaceuticals Inc.
NDC code
53329-302-14
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0427-2019

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.