FDA recall D-1129-2017

Product

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.

Distribution

CA, IL.

Key facts

Status

Terminated

Initiation date

2017-08-04

Report date

2017-09-13

Termination date

2020-11-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jiutepec, N/A, Mexico

Primary source

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