PlainRecalls
FDA Drug Moderate Class II Terminated

PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04

Reported: March 7, 2018 Initiated: February 15, 2018 #D-0546-2018

Product Description

PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04

Reason for Recall

Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.

Details

Recalling Firm
Medline Industries Inc
Units Affected
67,104 bottles
Distribution
Nationwide in the USA and Curacao
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04. Recalled by Medline Industries Inc. Units affected: 67,104 bottles.
Why was this product recalled?
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 7, 2018. Severity: Moderate. Recall number: D-0546-2018.