Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSION...

FDA Recall #F-0322-2023 — Class II — December 20, 2021

Recall #F-0322-2023 Date: December 20, 2021 Classification: Class II Status: Terminated

Product Description

Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Inositol DIETARY SUPPLEMENT 360 Capsules***Supplement Facts Serving Size: One Capsule***Inositol 920 mg***Other Ingredients: Vegetarian capsule (hypromellose and water) and vegetable stearate Professional Formulas PO Box 2034, Lake Oswego, OR 97035 Recommended Dosage: As a nutritional supplement, take one capsule up to 3 times daily, 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