FDA-Drug2018-02-07Class II

Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc
Hazard

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Sold states
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Affected count
288 cases
Manufactured in
Three Lakes Drive, Northfield, IL, United States
Products
Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2018

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