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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

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***"
Recall Number F-0594-2013
Classification Class I
Code Info Original Recalled Codes: 16 oz: LOT 34441C XXXXA EXP 03/2014 and 33.8 oz: LOT 34552C XXXXA EXP 03/2014 Expanded Recalled Codes: 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.
Product Distributed Qty 2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
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.

Event Detail

Event Id 62058
Product Type Food
Status Ongoing
Recalling Firm Botanical Laboratories Inc
City Ferndale
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate