Drug product

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.

D-0427-2019

December 07, 2018

Class II

Product summary

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

Code information: Lot # a) and b): 44G17, Exp. 05/2019

Distribution pattern: Nationwide within the United States

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

GMP Deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of specification