FDA recall Z-0529-2024

Product

PVP SOLUTION SING STRL, REF DYNDA1858

Reason for recall

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

Distribution

US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.

Key facts

Status

Ongoing

Initiation date

2023-11-03

Report date

2023-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2024