Why it was recalled
Product ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
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***"
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-0594-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 4, 2012
- FDA report date
- Nov 7, 2012
- Quantity
- 2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Botanical Laboratories Inc
Original FDA data
Every field from FDA enforcement report F-0594-2013, exactly as published.
Show all FDA fields
- City
- Ferndale
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 62058
- Address
- 1441 W Smith Rd
- Code information
- 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.
- Postal code
- 98248-8933
- Report date
- Nov 7, 2012
- Product type
- Food
- Recall number
- F-0594-2013
- Classification
- Class I
- Recalling firm
- Botanical Laboratories Inc
- Product quantity
- 2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
- Termination date
- Apr 3, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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***"
- Distribution pattern
- Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
- Recall initiation date
- Jun 4, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 1, 2012