FDA Recall United States Terminated Historical recordClass II
Professional Complementary Health Formulas, LLC
- Product
- Inositol packaged in white plastic bottle with UPC 406511156…
- Published
- February 8, 2023
- Distribution
- Nationwide
Professional Complementary Health Formulas, LLC Recall: Product recalled due to undeclared niacin.
United States
TerminatedClass II
- Company
- Professional Complementary Health Formulas, LLC
- Product
- Vitamin B Complex packaged in white plastic bottle labeled i…
- Recall date
- December 20, 2021
- Terminated
- April 3, 2023
- Source
- FDA
Reason for recall
Product recalled due to undeclared niacin.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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" | Not published in this source record | 299 bottles | Lot 1092715 |
Distribution
- Inositol was distributed in NY
- OR
- PA
- UT
- WI
- and WY. Vitamin B Complex was distributed nationwide.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0323-2023
- Event ID
- 91377
- Status
- Terminated
- Classification
- Class II
- Company
- Professional Complementary Health Formulas, LLC
- 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"
- Quantity
- 299 bottles
- Reason
- Product recalled due to undeclared niacin.
- Recall initiation date
- December 20, 2021
- Report date
- February 8, 2023
- Classification date
- Not published in this source record
- Termination date
- April 3, 2023
- Distribution pattern
- Inositol was distributed in NY, OR, PA, UT, WI, and WY. Vitamin B Complex was distributed nationwide.
- UPC, lot, and code information
- Lot 1092715
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Other products recalled under this same event
This recall shares FDA event ID 91377 with 1 other product entry in Public Health Trace.
Responsible company: Professional Complementary Health Formulas, LLC
Other recalls from Professional Complementary Health Formulas, LLC
FDA Recall United States Terminated Historical recordClass II
Professional Complementary Health Formulas, LLC
- Product
- Inositol packaged in white plastic bottle with UPC 406511156…
- Published
- February 8, 2023
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Professional Complementary Health Formulas, LLC
- Product
- Professional Formulas Sublinqual B12 High-Potency dietary su…
- Published
- August 9, 2017
- Distribution
- distributed in AZ, CA, CO, CT, FL, GA, H…
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| New York | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| Utah | 1 |
| Wisconsin | 1 |
| Wyoming | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
