MODERATE RISK Terminated 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 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

Recalled by FLAVORx Inc.

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

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.

Product Details

Product Quantity
420 bottles
Product Type
Food
Code Info
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
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
Thru out the United Sates and two foreign countries
Company Location
Columbia, MD, 21046-2882

Timeline

Report Date
12/13/2017
Recall Initiated
10/13/2017
Classification Date
12/06/2017
Termination Date
01/02/2018

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 29, 2026

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