Recall record at a glance
| Official record | F-0594-2013 |
|---|---|
| Category | Food Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Botanical Laboratories Inc. |
| Report date | Nov 7, 2012 |
| Recall initiation date | Jun 4, 2012 |
| Quantity | 2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains) |
| Location | Ferndale, WA, United States |
Official 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***"
Why the product was recalled
Product ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
Distribution information
Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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