FDA recall D-0546-2018

Product

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.

Distribution

Nationwide in the USA and Curacao

Key facts

Status

Terminated

Initiation date

2018-02-15

Report date

2018-03-07

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0546-2018