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

Recall Number: D-1735-2019

Firm: US Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20190821

Initiation Date: 20190711

Termination Date: 20200625

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.

Product Description

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