FDA-Drug2019-02-13Class II
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.
US Pharmaceuticals Inc.
Hazard
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Sold states
Nationwide within the United States
Affected count
7020 units
Manufactured in
681 Main St Ste 27, Belleville, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2019Don't want to check this manually?
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