US Pharmaceuticals Inc. recalls Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14)
Recalled February 13, 2019 · FDA recall D-0427-2019 · US Pharmaceuticals
Hazard
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample · FDA Class II
Units
7020 units
Sold at
Nationwide within the United States
Description
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Product
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.
Manufacturer(s)
US Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →