Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tu...
FDA Recall #D-0427-2019 — Class II — December 7, 2018
Product Description
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.
Reason for Recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recalling Firm
US Pharmaceuticals Inc. — Belleville, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7020 units
Distribution
Nationwide within the United States
Code Information
Lot # a) and b): 44G17, Exp. 05/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated