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Recall Observatory FDA recall evidence

Food product

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 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019 #50 per box 4oz bottles Package type: Amber Glass Boston Round Bottles

F-0428-2018

October 13, 2017

Class II

Product summary

Firm
FLAVORx Inc.
Event
Event 78554
Status
Terminated
Classification
Class II
Quantity
420 bottles
Official record key
food-enforcement:F-0428-2018

Official wording

Reason: 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.

Code information: 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 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8151712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #8311712 / Exp. Date 03/2019 Fillmaster Auto Sweetening Enhancer AQ, 4oz Bottle, Lot #9011712 / Exp. Date 03/2019

Distribution pattern: Thru out the United Sates and two foreign countries

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial growth