F-1112-2014 Class II Terminated

Recalled by Global Health Laboratories, LLC — Amityville, NY

FDA food recall F-1112-2014 was initiated by Global Health Laboratories, LLC on November 7, 2013 and is designated Class II. 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. The recall status is terminated (terminated March 10, 2017). Affected quantity: Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units.

Recall Details

Product Type
Food
Report Date
December 25, 2013
Initiation Date
November 7, 2013
Termination Date
March 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units

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

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.

Distribution Pattern

Arizona

Code Information

(a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B