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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description (a) ONEBODE Flo daily, probiotic enzyme digestive, 90 capsules, dietary supplement, Product No. T00135, UPC 0 14834 00135 5; (b) ONEBODE Flo for Family, probiotic enzyme digestive, 360 capsules, dietary supplement, Product No. T00109, UPC 0 14834 00109 6; (c) ONEBODE Flo daily, probiotic enzyme digestive, 6 capsules, dietary supplement (SAMPLE PACK), Product No. T00111, UPC 0 14834 00111 9 --- Mfg. for OneBode, Chandler, Arizona 85226
Recall Number F-1112-2014
Classification Class II
Code Info (a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B
Product Distributed Qty Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units
Reason For Recall The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.

Event Detail

Event Id 66766
Product Type Food
Status Ongoing
Recalling Firm Global Health Laboratories, LLC
City Amityville
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Arizona