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.

Recall Number: D-0427-2019

Firm: US Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20190213

Initiation Date: 20181207

Termination Date: 20231106

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

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.