FLAVORx Sweetening Enhancer , the product is packaged as follows: Vet Sweetening…
FLAVORx Inc. recalled this product and the FDA reported the enforcement action on 13 December 2017 as Class II. The recall was initiated by the firm. 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.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- 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
- Reason for recall
- 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.
- Recalling firm
- FLAVORx Inc.
- Firm location
- Columbia, Maryland, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0429-2018
- Quantity
- 2068 bottles
- Distribution
- Thru out the United Sates and two foreign countries
- Initiated
- 13 October 2017
- Reported by FDA
- 13 December 2017
- Terminated
- 2 January 2018
- Firm notified by
- Product codes
- Vet Sweetening Enhancer AQ, 2oz Bottle, Lot #161269 / Exp. Date 12/2018
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 3 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 3 of them.
- The recall ran for 3 months, from 13 October 2017 to termination on 2 January 2018. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 2 months after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Other records from FLAVORx Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 3 records for FLAVORx Inc.
All 2017 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.