Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COM...

FDA Recall #F-0323-2023 — Class II — December 20, 2021

Recall #F-0323-2023 Date: December 20, 2021 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Professional Complementary Health Formulas, LLC — Lake Oswego, OR

Classification

Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Product Type

Food

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated