PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 13, 2017 Initiated: August 4, 2017 #D-1129-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Degasa Sa De Cv
Units Affected
720 bottles
Distribution
CA, IL.
Location
Jiutepec, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Degasa Sa De Cv. Units affected: 720 bottles.
Why was this product recalled?
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 13, 2017. Severity: Moderate. Recall number: D-1129-2017.