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Class II: temporary or reversible health riskTerminated

Professional Complementary Health Formulas Inositol packaged in white plastic bottle Recall

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

Professional Complementary Health Formulas, LLC · Lake Oswego, OR

Risk level
Class II
Reported by FDA
Feb 8, 2023
Recall ID
F-0322-2023
Check your lot numberHow we source this data

Summary

Professional Complementary Health Formulas recalled Inositol packaged in white plastic bottle starting Dec 20, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0322-2023 on Feb 8, 2023. Reason: Product recalled due to undeclared niacin. Status: Terminated.

Why it was recalled

Product recalled due to undeclared niacin.

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 numbers, UPCs & expiration codes

Lot 1032526

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0322-2023
Classification
Class II
Status
Terminated
Recall initiated
Dec 20, 2021
FDA report date
Feb 8, 2023
Quantity
40 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Professional Complementary Health Formulas, LLC

Original FDA data

Every field from FDA enforcement report F-0322-2023, exactly as published.

Show all FDA fields
City
Lake Oswego
State
OR
Status
Terminated
Country
United States
Event ID
91377
Address
5550 Rosewood St
Code information
Lot 1032526
Postal code
97035-5371
Report date
Feb 8, 2023
Product type
Food
Recall number
F-0322-2023
Classification
Class II
Recalling firm
Professional Complementary Health Formulas, LLC
Product quantity
40 bottles
Termination date
Apr 3, 2023
Reason for recall
Product recalled due to undeclared niacin.
Voluntary / mandated
Voluntary: Firm initiated
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"
Distribution pattern
Inositol was distributed in NY, OR, PA, UT, WI, and WY. Vitamin B Complex was distributed nationwide.
Recall initiation date
Dec 20, 2021
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Jan 30, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0322-2023, published Feb 8, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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