FDA recall F-1222-2024

HTO Nevada Inc DBA Kirkman · Class III · food

Product

Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120 capsules per package, UPC 8 12325 02354 7. Manufactured exclusively by: Kirkman, Lake Oswego, OR 9703,

Reason for recall

Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg).

Distribution

Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.

Key facts

Status
Terminated
Initiation date
2024-03-12
Report date
2024-05-15
Termination date
2024-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Oswego, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1222-2024