Colon Therapy bulk capsules recall

Recalled by Sunset Natural Products Inc. · Miami, FL, United States

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

These are failures of the safety steps that keep food safe - cooking, pasteurising, keeping cold, sealing - even when no contaminant has yet been found. All processing & sanitation problems recalls.

What was recalled

Colon Therapy, bulk capsules

Quantity: 19,455,300

Food: Dietary supplements

Lot codes, dates and UPCs

A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.

As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 020514 Exp. Date 05/17, Lot # 030514 Exp. Date 05/17, Lot # 040514 Exp. Date 05/17, Lot # 140514 Exp. Date 06/17, Lot # 150514 Exp. Date 06/17, Lot # 440514 Exp. Date 05/17, Lot # 500514 Exp. Date 05/17, Lot # 510514 Exp. Date 05/17, Lot # 520514 Exp. Date 05/17, Lot # 530514 Exp. Date 05/17, Lot # 540514 Exp. Date 06/17, Lot # 550514 Exp. Date 06/17, Lot # 560514 Exp. Date 06/17, Lot # 570514 Exp. Date 06/17, Lot # 580514 Exp. Date 06/17, Lot # 590514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 610514 Exp. Date 06/17, Lot # 620514 Exp. Date 07/17, Lot # 020714 Exp. Date 07/17, Lot # 240714 Exp. Date 07/17,Lot # 250714 Exp. Date 07/17, Lot # 260714 Exp. Date 07/17, Lot # 270714 Exp. Date 07/17, Lot # 280714 Exp. Date 07/17, Lot # 290714 Exp. Date 07/17, Lot # 300714 Exp. Date 07/17, Lot # 310714 Exp. Date 08/17, Lot # 320714 Exp. Date 08/17, Lot # 330714 Exp. Date 08/17, Lot # 340714 Exp. Date 08/17, Lot # 350714 Exp. Date 08/17, Lot # 380714 Exp. Date 09/17, Lot # 390714 Exp. Date 09/17, Lot # 400714 Exp. Date 09/17, Lot # 410714 Exp. Date 10/17, Lot # 280814 Exp. Date 10/17, Lot # 290814 Exp. Date 10/17, Lot # 300814 Exp. Date 10/17, Lot # 310814 Exp. Date 10/17, Lot # 320814 Exp. Date 10/17, Lot # 230914 Exp. Date 09/17, Lot # 270914 Exp. Date 10/17, Lot # 081014 Exp. Date 11/17, Lot # 091014 Exp. Date 11/17, Lot # 020615 Exp. Date 07/18, Lot # 040615 Exp. Date 07/18, Lot # 170615 Exp. Date 07/18, Lot # 180615 Exp. Date 08/18, Lot # 390615 Exp. Date 08/18, Lot # 480615 Exp. Date 08/18, Lot # 160715 Exp. Date 07/18

Where it was sold

Florida Nevada

FDA's distribution note: Products distributed to Florida, Nevada and the Dominican Republic

Check the codes, then return or discard. Class II means eating it may cause temporary or reversible health problems. If your package matches the recalled codes, do not eat it - return it to the store or throw it away. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.

Recalling firm: Sunset Natural Products Inc.
Initiated by: FDA Mandated
Recall initiated: Oct 13, 2015
In FDA report of: Jan 4, 2017
Terminated: Apr 10, 2017
FDA recall number: F-0978-2017 · event 74054
Official record: FDA enforcement report search

Also recalled with it (162 more products)

FDA files each product of one recall action separately; these share the same FDA event.

Class II · Moderate risk Terminated Processing Oct 13, 2015

Bionix

Reason Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or…

Sunset Natural Products Inc. FL, NV F-0909-2017

Class II · Moderate risk Terminated Processing Oct 13, 2015

Other recalls by Sunset Natural Products Inc.

Class II · Moderate risk Terminated Processing Oct 5, 2015

Colon Therapy bulk capsules recall

Why it was recalled

What was recalled

Lot codes, dates and UPCs

Where it was sold

Also recalled with it (162 more products)

Bionix

Performens

SoMaks

Project #2

Project #3

Nutra Pro

Oxy Extreme

Test Booster

Fat Burner

Thor, 60 capsules per bottle

Night Stallion (80

Crea Care (100

Other recalls by Sunset Natural Products Inc.

Hepasil sold in bulk of 500

Venocell sold in bulk of 50

Prostax Forte sold in bulk of 50

Prostamax DUO