FDAClass IIFebruary 13, 2019

Soothe & Cool Protect Moisture Guard Skin Protectant recall: Contamination

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL…

Why was Soothe & Cool Protect Moisture Guard Skin Protectant recalled?

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019

Product
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL…
Recalling firm
US Pharmaceuticals Inc.
Quantity
19752 units
Distribution
Nationwide within the United States
Recall date
February 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls