FDA recall F-0323-2023

Professional Complementary Health Formulas, LLC · Class II · food

Product

Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIETARY SUPPLEMENT 60 Capsules***Supplement Facts Serving Size: One Capsule***Vitamin B1 (as thiamine Hcl) 80mg 6667% Vitamin B2 (as riboflavin) 80 mg 6154% Vitamin B3 (as niacinamide) 80 mg NE 500% Vitamin B6 (as pyridoxine HCl) 80 mg 4706% Folic acid 667 mcg DFE 167% Vitamin B12 (as cyanocobalamin) 80 mcg 3333% Biotin 300 mcg 1000% Vitamin B5 (as calcium pantothenate) 80 mg 1600% Choline (as bitartrate) 80 mg 15%***Professional Formulas PO Box 2034, Lake Oswego, OR 97035 Recommended Dosage: As a nutritional supplement, take one capsule, or as directed by your healthcare professional***FOR PROFESSIONAL USE ONLY"

Reason for recall

Product recalled due to undeclared niacin.

Distribution

Inositol was distributed in NY, OR, PA, UT, WI, and WY. Vitamin B Complex was distributed nationwide.

Key facts

Status
Terminated
Initiation date
2021-12-20
Report date
2023-02-08
Termination date
2023-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Oswego, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0323-2023