FDA-Drug2017-09-13Class II

Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09

Degasa Sa De Cv
Hazard

Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.

Sold states
CA, IL.
Affected count
720 bottles
Manufactured in
Calle Centenario 15, Col. DEPORTIVA, Jiutepec, N/A, Mexico
Products
Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1129-2017

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