Product is a liquid dietary supplement packaged in white plastic bottles with...
FDA Recall #F-0594-2013 — Class I — June 4, 2012
Recall Summary
| Recall Number | F-0594-2013 |
| Date Initiated | June 4, 2012 |
| Classification | Class I |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Botanical Laboratories Inc |
| Location | Ferndale, WA |
Product Description
Product is a liquid dietary supplement packaged in white plastic bottles with a shrink wrap sleeve label. The product comes in 3 sizes, 2 oz, 16oz. and 33.8oz. The product label reads in part: "Fast Absorbing Liquid 1-OZ A DAY***WELLESSE***Digestive 3-in-1 Health Soluble Fiber Prebiotics Aloe Vera Promotes Gentle Regularity Supports Health Bacteria Balances Stomach Acidity***Isomaltooligosaccharides (Prebiotic Fiber),***Galactooligosaccharides***Other Ingredients: Purified Water***Manufactured By: Botanical Laboratories, Inc. Ferndale, WA 98248 USA***"
Reason for Recall
Product ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
Classification
Class I — A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution Pattern
Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
Product Quantity
2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
Product Codes / Lot Numbers
Original Recalled Codes: 16 oz: LOT 34441C XXXXA EXP 03/2014 and 33.8 oz: LOT 34552C XXXXA EXP 03/2014 Expanded Recalled Codes: (Note: When the recall was expanded, the 2 ounce size was added to the recall.) 33923A XXXXA EXP 12/2012, 33973A XXXXA EXP 12/2012, 34011A XXXXA EXP 10/2012, 34068A XXXXA EXP 12/2012, 34148A XXXXA EXP 12/2012, 34190B XXXXA EXP 01/2013, 34309B XXXXA EXP 03/2013, 34310B XXXXA EXP 03/2013, 34346B XXXXA EXP 03/2013, 34400B XXXXA EXP 08/2013 and 34406B XXXXA EXP 08/2013 The first five digits are uniquely generated by an inventory management program - Macola - followed by a letter representing the year. XXXX signifies a four digit variable time code stamp, followed by a letter designating the compound vessel used. Below is the expiration month and year.
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.
Salmonella symptoms typically begin 6 hours to 6 days after consuming contaminated food and include diarrhea, fever, stomach cramps, and vomiting. Most people recover within 4 to 7 days without medical treatment. However, Salmonella can spread from the intestines to the bloodstream, and from there to other parts of the body. Young children under 5, adults over 65, and people with weakened immune systems are most vulnerable. Seek medical attention immediately if you have severe diarrhea (more than 3 loose stools in 24 hours), a fever above 102°F, bloody stool, or signs of dehydration.
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.