FDA-Drug2019-08-21Class II

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

US Pharmaceuticals Inc.
Hazard

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Sold states
Distributed Nationwide in the USA
Affected count
830 tubes
Manufactured in
681 Main St Ste 27, N/A, Belleville, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1735-2019

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