Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE…
The Kroger Co recalled this product and the FDA reported the enforcement action on 13 December 2017 as Class II. The recall was initiated by the firm. the firm received a complaint of mold found in the 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
- Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
- Reason for recall
- the firm received a complaint of mold found in the product.
- Recalling firm
- The Kroger Co
- Firm location
- Cincinnati, Ohio, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0493-2018
- Quantity
- 107,874 cs/ (4 x 1 gallon jugs) and 1 gallon jugs
- Distribution
- Product was shipped to the following states: AL, AR, GA, IL, IN, KY, MI, MO, MS, NC, OH, SC, TN, VA & WV.
- Initiated
- 3 July 2017
- Reported by FDA
- 13 December 2017
- Terminated
- 14 March 2018
- Firm notified by
- Product codes
- Plant Code:: 51-4140 SELL BY: 05/18/18, SELL BY APR 26 18 THRU OCT 10 18
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 8 months, from 3 July 2017 to termination on 14 March 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 distribution pattern names 12 states, and the FDA published the enforcement report 5 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.
Named in the distribution pattern: Arkansas, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, Mississippi, North Carolina, Ohio, South Carolina, Tennessee. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Spoilage and mould
A spoilage recall means the food degraded before its date: mould growth, unintended fermentation, swelling or rancidity, usually traced to a seal, a formulation or a storage temperature.
A preventive controls plan covers spoilage under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.93
- Warehousing and distribution: storage and transport under conditions that protect food against contamination and against deterioration of the food and its container.
- 21 CFR 117.80(b)(3)
- Time and temperature: holding food at temperatures that do not allow microorganisms to grow, and for no longer than the process allows.
Other records from The Kroger Co
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 90 other records name this firm.
All 91 records for The Kroger Co
All 2017 recalls · All FDA food recall data
21 CFR 117.93 is the clause behind this recall, and it is one 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.