Product: Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
Reason for recall: CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated: 20190711
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated