FDA recall Z-1837-2021

Product

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

Reason for recall

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

Distribution

Worldwide distribution - US Nationwide distribution and the country of Mexico.

Key facts

Status

Terminated

Initiation date

2021-05-21

Report date

2021-06-16

Termination date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1837-2021