The Recall Desk
HighFDA (Food)·F-0429-2018·Announced 2017-12-13

FLAVORx Recalls Sweetening Enhancer Due to Microbial Growth

FLAVORx Inc. is recalling specific bottles of Sweetening Enhancer because testing revealed microbial growth. The product is a pharmacy compounding material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves microbial growth in a product used for pharmacy compounding. While no specific illnesses are reported in the text, the presence of microbial growth in a medical/pharmaceutical context represents a significant risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

FLAVORx Inc. has initiated a recall of its Sweetening Enhancer product, specifically the Vet Sweetening Enhancer AQ, 2oz Bottle. The affected items are identified by Lot #161269 and have an expiration date of 12/2018. The product is packaged in amber glass Boston round bottles.

The recall was initiated because subsequent testing within the company's ongoing stability program indicated the presence of microbial growth in the sweetening enhancer. The product is described as a food additive used as a pharmacy compounding material.

A total of 2,068 bottles were distributed throughout the United States and two foreign countries. Consumers and pharmacy compounding facilities should check their inventory for this specific lot number and expiration date. If found, the product should be discontinued from use and returned to the distributor or disposed of according to local regulations.

The recalled product

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
Manufacturer
FLAVORx Inc.
Affected units
2,068

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Vet Sweetening Enhancer AQ
  • 2oz Bottle
  • Lot #161269 / Exp. Date 12/2018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by FLAVORx Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · FLAVORx Inc.

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