FDA recall F-0543-2021

Twenty-First Century Healthcare, Inc · Class II · food

Product

21st Century Vitamin D3 125 mcg (5000 IU) tablet, 100 count, UPC 7-40985-27431-6, 21st Century HealthCare, Inc., 2119 Wilson St., Tempe, AZ 85282

Reason for recall

A small quantity of bottles of Vitamin D3 125 mcg ((5000 IU) 100 ct. were mislabeled as Vitamin D3 25 mcg (1000 IU). Secondary labeling on the bottles (back label) is correctly labeled as Vitamin D3 125 mcg (5000 IU).

Distribution

Key facts

Status: Terminated
Initiation date: 2021-05-07
Report date: 2021-05-26
Termination date: 2021-09-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0543-2021