FDA Recall United States TerminatedTerminated: June 7, 2019Historical recordClass II
Threshold Enterprises Ltd
- Product
- Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count,…
- Published
- March 6, 2019
- Distribution
- Nationwide
Threshold Enterprises Ltd Recall: Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation. - F-0061-2020
United States
TerminatedClass III
- Company
- Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Brain Charge Advanced…
- Recall date
- September 10, 2019
- Terminated
- February 3, 2020
- Source
- FDA
Reason for recall
Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143 | 021078026136 | 1,822 bottles | Lot Number: FG-99741, FG-100206, FG-99742, FG-100207 |
Distribution
- U.S. distribution to the following: AL
- AZ
- CA
- CO
- FL
- GA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MO
- NC
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- TN
- TX
- UT
- WA No foreign distribution.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0061-2020
- Event ID
- 84038
- Status
- Terminated
- Classification
- Class III
- Company
- Threshold Enterprises Ltd
- Product description
- Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143
- Quantity
- 1,822 bottles
- Reason
- Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- Recall initiation date
- September 10, 2019
- Report date
- October 30, 2019
- Classification date
- Not published in this source record
- Termination date
- February 3, 2020
- Distribution pattern
- U.S. distribution to the following: AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, UT, WA No foreign distribution.
- UPC, lot, and code information
- UPC 021078026136; Lot Number: FG-99741, FG-100206, FG-99742, FG-100207
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Letter
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Threshold Enterprises Ltd
Other recalls from Threshold Enterprises Ltd
FDA Recall United States TerminatedTerminated: August 2, 2017Historical recordClass II
Threshold Enterprises Ltd
- Product
- Planetary Herbals Ginseng Classic; Classic Chinese Energize…
- Published
- August 9, 2017
- Distribution
- CA, MN, WA, IL, PR, ME, SD.
FDA Recall United States TerminatedTerminated: July 10, 2017Historical recordClass II
Threshold Enterprises Ltd
- Product
- Source Naturals Renewal Antioxidant Tablet: 10 Count Sample…
- Published
- July 19, 2017
- Distribution
- Nationwide
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 |
|---|---|
| Alabama | 1 |
| Arizona | 1 |
| California | 1 |
| Colorado | 1 |
| Florida | 1 |
| Georgia | 1 |
| Illinois | 1 |
| Indiana | 1 |
| Kansas | 1 |
| Kentucky | 1 |
| Louisiana | 1 |
| Massachusetts | 1 |
| Maryland | 1 |
| Michigan | 1 |
| Missouri | 1 |
| North Carolina | 1 |
| New Hampshire | 1 |
| New Jersey | 1 |
| New Mexico | 1 |
| Nevada | 1 |
| New York | 1 |
| Ohio | 1 |
| Oklahoma | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| Puerto Rico | 1 |
| Tennessee | 1 |
| Texas | 1 |
| Utah | 1 |
| Washington | 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.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.
New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
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 III mean?
FDA classifies this recall as Class III. See how to read an FDA recall record (linked above) for what each classification level means.
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 responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.
Official guidance and record verification
Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.
How to interpret this historical record
This record is preserved as published by FDA, as of February 3, 2020.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
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.