Food recall: Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7…
Class II FDA enforcement event 70761. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
ProThera, Inc. started this food recall on 13 Mar 2015. The firm address in the FDA record is in Reno, NV. FDA put the recall in Class II. FDA event 70761 has 2 product records. The first FDA enforcement report date is 22 Apr 2015. The record gives the status Terminated, with the termination date 1 Jul 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.
Recalling firm
ProThera, Inc., Reno, NV.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1953-2015 | Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement 60 Vegetarian Capsules. UPC 7 09616 01248 2 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV. | lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles | Class II | Terminated | 22 Apr 2015 |
| F-1954-2015 | Klaire Labs Ther-Biotic Children's Chewable 125+ Billion CFU's Multi-Species Probiotic Supplement 60 Chewable Capsules. UPC 7 09616 01247 5 Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV. | 3,484 total bottles | Class II | Terminated | 22 Apr 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Food events that started in 2015
- 607
- Share of these events in Class II
- 46%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Nov 2013 | Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supp | Food | Class II | 2 |
| 10 Oct 2013 | Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 280 | Food | Class II | 5 |
Official channels
- FDA enforcement report F-1953-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 70761. https://recallregister.com/fda/ii/70761/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.
- What quantity of product is in FDA event 70761?
- The event has 2 product records. The first record gives this quantity:
lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2015 have the same class?
- 46% of the 607 food events that started in 2015 are in Class II.