Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTA
Summary
The FDA issued a Class II for Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in par by Professional Complementary Health Formulas, LLC. Reason: Product recalled due to undeclared niacin..
Details
Source
Food Recall
External ID
F-0322-2023
Action Date
2023-02-08
Status
Terminated
Category
food
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"
Lot/Code Info: Lot 1032526
Quantity Affected: 40 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-20
Company
Lake Oswego, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 32 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Professional Complementary Health Formulas, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Professional Complementary Health Formulas, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Professional Complementary Health Formulas, LLC have FDA actions?
Professional Complementary Health Formulas, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0322-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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