Recall record at a glance
| Official record | F-1112-2014 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Global Health Laboratories, LLC |
| Report date | Dec 25, 2013 |
| Recall initiation date | Nov 7, 2013 |
| Quantity | Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles; Sample packs: 11,276 units |
| Location | Amityville, NY, United States |
Official 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
Why the product 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.
Distribution information
Arizona
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
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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