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.
Reason for recall: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recall initiated: 20181207
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated