Food recall: FLAVORx Sweetening Enhancer , the product is packaged as follows: "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot…
Class II FDA enforcement event 78554. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
FLAVORx Inc. has decided to recall the following product FLAVORx Sweetening Enhancer, which is a food additive used as a Pharmacy Compounding Material, because of subsequent testing of the product in there ongoing stability program indicated that there was microbial growth in their sweetening enhancer product.
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
FLAVORx Inc. started this food recall on 13 Oct 2017. The firm address in the FDA record is in Columbia, MD. FDA put the recall in Class II. FDA event 78554 has 3 product records. The first FDA enforcement report date is 13 Dec 2017. The record gives the status Terminated, with the termination date 2 Jan 2018.
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.
Thru out the United Sates and two foreign countries
Recalling firm
FLAVORx Inc., Columbia, MD.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0427-2018 | FLAVORx Sweetening Enhancer , the product is packaged as follows: "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #161269 / Exp. Date 12/2018 "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #170361 / Exp. Date 03/2019 #100 per box 1oz bottles, #50 per box 4oz bottles Package type: Amber Glass Boston Round Bottles | 24600 Bottles | Class II | Terminated | 13 Dec 2017 |
| F-0428-2018 | FLAVORx Sweetening Enhancer , the product is packaged as follows: Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #3281712 / Exp. Date 12/2018 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #4281712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #5181712 / Exp. Date… | 420 bottles | Class II | Terminated | 13 Dec 2017 |
| F-0429-2018 | FLAVORx Sweetening Enhancer , the product is packaged as follows: Vet Sweetening Enhancer AQ, 2oz Bottle, Lot #161269 / Exp. Date 12/2018 Package type: Amber Glass Boston Round Bottles | 2068 bottles | Class II | Terminated | 13 Dec 2017 |
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 2017
- 599
- Share of these events in Class II
- 52%
- Product records in this event
- 3
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report F-0427-2018The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 78554. https://recallregister.com/fda/ii/78554/. 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:
Thru out the United Sates and two foreign countries
- What quantity of product is in FDA event 78554?
- The event has 3 product records. The first record gives this quantity:
24600 Bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2017 have the same class?
- 52% of the 599 food events that started in 2017 are in Class II.