FDA recall record
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 lab...
FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.
FDA listed a termination date of April 3, 2013. openFDA does not treat this as a live recall-status tracker.
Product described in an FDA recall
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. 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
Product ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
Products involved
Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.
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. 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***"
Code information listed by FDA
) 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.
Distribution and firm information
Recalling firm listed by FDA: Botanical Laboratories Inc
Firm location listed by FDA: Ferndale, WA, United States
Distribution reported by FDA: Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
Product quantity listed by FDA: 2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
Source
Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.
Official FDA openFDA food enforcement record
Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.