Class IITerminated · reported 2014-12-17

ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for…

Nature's Way Purewater Systems, Inc. recalled this product and the FDA reported the enforcement action on 17 December 2014 as Class II. The recall was initiated by the firm. Product may contain mold.

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: ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bothell WA 98021 Packaging: For 33.8 fl oz (1.0 liter) plastic bottles: Wholesale: flats with 2- 6 packs per flat; 12 - bottle box. Retail sale: 6-packs of 1 liter bottles and as individual bottles. For the 50.7 fl oz. (1.5 liter) plastic bottles: Wholesale: packed in 12 bottles per case. Retail sale: Individual bottles. For the 20 fl oz plastic bottles: Wholesale: 24 bottle case; 24 bottle tray; 4 - 6 pack trays. Retail sale: Individual bottles and 6-packs (retail).
Reason for recall: Product may contain mold.
Recalling firm: Nature's Way Purewater Systems, Inc.
Firm location: Pittston, Pennsylvania, United States
Classification: Class II
Status: Terminated
Recall number: F-0615-2015
Quantity: 1.5 L - 10,890 cs, 12 bottles per case; 1L - 14,270 cs, 12 bottles per case; 20 oz. - 5724 cs, 24 bottle per case
Distribution: CT, DE, GA, IA, IL, IN, MA, MD, ME, MI, MN, NC, NH, NY, PA, VA, and WI
Initiated: 31 October 2014
Reported by FDA: 17 December 2014
Terminated: 9 September 2015
Firm notified by: Telephone
Product codes: JUL 22 2014 time NW1 Best by Jul 21 2016; Jul 23 2014 time NW1 Best by Jul 22 2016; Jul 24 2014 time NW1 Best by Jul 23 2016; and Jul 25 2014 time NW1 Best by Jul 24 2016

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 10 months, from 31 October 2014 to termination on 9 September 2015. 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 17 states, and the FDA published the enforcement report 7 weeks 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: Connecticut, Delaware, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Hampshire, New York, Pennsylvania, Virginia, Wisconsin. 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.

All 2014 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 access

Recall 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.