FDA Recall Terminated Historical recordClass II
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
- Reason
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Published
- February 13, 2019
- Distribution
- Nationwide
