FDAFDA · Food and drugs·Recall number D-0427-2019
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
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 # a) and b): 44G17, Exp. 05/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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