Pro Bioteks Laboratories Recall: Bio-35 has undeclared soy lecithin.
United States
TerminatedClass II
- Company
- Pro Bioteks Laboratories
- Product
- Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Sup…
- Recall date
- September 15, 2017
- Terminated
- December 12, 2017
- Source
- FDA
Reason for recall
Bio-35 has undeclared soy lecithin.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules. UPC 0-26341-12900-2 | 0-26341-12900-2 | 600,000 soft gel capsules | Lot# 2037055 Exp 06/12/2020 |
Distribution
- Nationwide to AZ
- CA
- CO
- FL
- ID
- LA
- Ml
- MN
- MO
- NM
- NV
- OR
- TX
- UT
- WA
- WY. No foreign/VA/govt/military consignees.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0009-2018
- Event ID
- 78139
- Status
- Terminated
- Classification
- Class II
- Company
- Pro Bioteks Laboratories
- Product description
- Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules. UPC 0-26341-12900-2
- Quantity
- 600,000 soft gel capsules
- Reason
- Bio-35 has undeclared soy lecithin.
- Recall initiation date
- September 15, 2017
- Report date
- October 11, 2017
- Classification date
- Not published in this source record
- Termination date
- December 12, 2017
- Distribution pattern
- Nationwide to AZ, CA, CO, FL, ID, LA, Ml, MN, MO, NM, NV, OR, TX, UT, WA, WY. No foreign/VA/govt/military consignees.
- UPC, lot, and code information
- UPC 0-26341-12900-2; Lot# 2037055 Exp 06/12/2020
- 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
Responsible company: Pro Bioteks Laboratories
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 |
|---|---|
| Arizona | 1 |
| California | 1 |
| Colorado | 1 |
| Florida | 1 |
| Idaho | 1 |
| Louisiana | 1 |
| Minnesota | 1 |
| Missouri | 1 |
| New Mexico | 1 |
| Nevada | 1 |
| Oregon | 1 |
| Texas | 1 |
| Utah | 1 |
| Washington | 1 |
| Wyoming | 1 |
| Virginia | 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.
