FDA Recall Terminated Historical recordClass II
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
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
