Why it was recalled
The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.
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
Lot numbers, UPCs & expiration codes
(a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B
Where it was sold
Arizona
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1112-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2013
- FDA report date
- Dec 25, 2013
- Quantity
- Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Health Laboratories, LLC
Original FDA data
Every field from FDA enforcement report F-1112-2014, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66766
- Address
- 9500 New Horizons Blvd
- Code information
- (a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B
- Postal code
- 11701-1155
- Report date
- Dec 25, 2013
- Product type
- Food
- Recall number
- F-1112-2014
- Classification
- Class II
- Recalling firm
- Global Health Laboratories, LLC
- Product quantity
- Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units
- Termination date
- Mar 10, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Arizona
- Recall initiation date
- Nov 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 18, 2013