Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured ...
FDA Recall #D-0425-2019 — Class II — December 7, 2018
Product Description
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 for Recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recalling Firm
US Pharmaceuticals Inc. — Belleville, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
19752 units
Distribution
Nationwide within the United States
Code Information
Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated