Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packa...

FDA Recall #F-2104-2012 — Class II — July 31, 2012

Recall Summary

Recall NumberF-2104-2012
Date InitiatedJuly 31, 2012
ClassificationClass II
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmFour Brothers Packaging Corporation
LocationOak Park, MI

Product Description

Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223

Reason for Recall

New York State Department of Agriculture sampled the product and found undeclared colors in Jakes Candy Spice Drops. The firm was notified on 4/19/2012 via letter from New York. FDA conducted follow up and associated inspections on 6/29/12, 7/26/12 and 7/27/12 and determined the labels continued to have the undeclared colors, including FD & C Red 40, Yellow 6, Blue1 and Red 3.

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

MI distribution only...others unknown

Product Quantity

UNKNOWN

Product Codes / Lot Numbers

Packaging is labeled with a best buy date of 1 year from repackaging date.

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.

If you have a food allergy and consumed the recalled product, monitor yourself closely for allergic reaction symptoms — including hives, swelling, difficulty breathing, nausea, vomiting, or anaphylaxis. If you experience any symptoms, seek medical attention immediately. For anaphylaxis (severe allergic reaction with difficulty breathing, rapid heartbeat, or loss of consciousness), call 911 and use an epinephrine auto-injector (EpiPen) if available. Stop consuming the product and check all products from the same manufacturer for similar labeling issues, as undeclared allergens sometimes affect multiple products from the same production facility.

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.