Soothe&Cool Protect Moisture Guard Skin Protectant recalled over manufacturing violations
- Recall date
- July 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- US Pharmaceuticals Inc. recalls Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mu…
- Recall number
- D-1735-2019
- FDA classification
- Class II
- Brand / firm
- US Pharmaceuticals Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever US Pharmaceuticals Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: US Pharmaceuticals Inc.