ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manuf...

FDA Recall #F-0615-2015 — Class II — October 31, 2014

Recall Summary

Recall NumberF-0615-2015
Date InitiatedOctober 31, 2014
ClassificationClass II
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmNature's Way Purewater Systems, Inc.
LocationPittston, PA

Product Description

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.

Classification

Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution Pattern

CT, DE, GA, IA, IL, IN, MA, MD, ME, MI, MN, NC, NH, NY, PA, VA, and WI

Product 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

Product Codes / Lot Numbers

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

What Should You Do?

Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.

Frequently Asked Questions

Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.

In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.

Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.

The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.