FDAFDA · Food and drugs·Recall number D-0425-2019
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
Published February 13, 2019 · Recall initiated: December 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Pharmaceuticals Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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