FDA recall F-0322-2023

Professional Complementary Health Formulas, LLC · Class II · food

Product

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.

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-0322-2023