FDA recall Z-0308-2024

Microbiologics Inc · Class II · device

Product

LYFO-DISK, P. venetum, Catalog number 0794L

Reason for recall

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Distribution

Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.

Key facts

Status
Ongoing
Initiation date
2023-10-18
Report date
2023-11-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0308-2024