Source Naturals Renewal Antioxidant Tablet: 10 Count Sample Pack, 30 Count, ...
FDA Recall #F-2383-2017 — Class II — September 11, 2015
Recall Summary
| Recall Number | F-2383-2017 |
| Date Initiated | September 11, 2015 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Threshold Enterprises Ltd |
| Location | Scotts Valley, CA |
Product Description
Source Naturals Renewal Antioxidant Tablet: 10 Count Sample Pack, 30 Count, 60 Count, & 120 Count per bottle; Ingredient: Maltodextrin, Cellulose (Capsules, Silica and magnesium stearate; 30 count Bottle - Product SN1750: 60 count Bottle - Product SN1751; 120 count Bottle - Product SN1752; 10 Count Sample Packs - Product SN5024. Manufactured for Source Naturals, Santa Cruz, CA
Reason for Recall
Dietary supplements contain low levels of undeclared boron
Classification
Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution Pattern
Nationwide only.
Product Quantity
9,361 units
Product Codes / Lot Numbers
30 Count bottles: Lot No. QTY Exp. FG-13852 76 12/15 FG-14726 148 12/15 FG-19274 148 03/16 FG-24304 148 03/16 FG-30636 100 03/16 FG-37569 9 03/16 FG-39616 172 07/17 FG-47423 64 07/17 FG-50614 70 07/17 FG-65266 60 07/17 FG-65266 60 07/17 FG-59256 144 09/18 60 count bottles: Lot No. QTY Exp. FG-13853 338 12/15 FG-14725 468 12/15 FG-19145 290 03/16 FG-23361 206 03/16 FG-23362 396 03/16 FG-34451 98 03/16 FG-38199 38 03/16 FG-39615 424 07/17 FG-50331 122 07/17 FG-53623 144 07/17 FG-59257 362 09/18 FG-65017 206 09/18 120 count bottles: LOT QTY EXP FG-13854 134 12/15 FG-14556 141 12/15 FG-15360 213 12/15 FG-19882 302 03/16 FG-23397 350 03/16 FG-29559 160 03/16 FG-32109 215 03/16 FG-32109 215 03/16 FG-37240 60 03/16 FG-38639 42 03/16 FG-39812 444 07/17 FG-45840 266 07/17 FG-51761 200 07/17 FG-59258 482 09/18 FG-64221 218 09/18 FG-65613 395 09/18; 10 count sample packs; Lot No. QTY Exp. FG-13855 41 12/15 FG-30136 108 03/16 FG-34834 95 03/16 FG-39626 200 07/17 FG-43530 277 07/17 FG-51677 150 07/17 FG-59259 362 09/18
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
If you have a food allergy and consumed the recalled product, monitor yourself closely for allergic reaction symptoms — including hives, swelling, difficulty breathing, nausea, vomiting, or anaphylaxis. If you experience any symptoms, seek medical attention immediately. For anaphylaxis (severe allergic reaction with difficulty breathing, rapid heartbeat, or loss of consciousness), call 911 and use an epinephrine auto-injector (EpiPen) if available. Stop consuming the product and check all products from the same manufacturer for similar labeling issues, as undeclared allergens sometimes affect multiple products from the same production facility.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.