FDA recall F-0427-2018

FLAVORx Inc. · Class II · food

Product

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

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.

Distribution

Thru out the United Sates and two foreign countries

Key facts

Status
Terminated
Initiation date
2017-10-13
Report date
2017-12-13
Termination date
2018-01-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0427-2018