RLRecall Lot Watch
Recall profile

Sunset Natural Products Inc. recall details, lot review, and report.

Sunset Natural Products Inc. recall for Colon Therapy, bulk capsules is listed as Class II with status Terminated. 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 distributed since April 2, 2014, hire a cGMP expe

What to verify against the product or inventory

Use the public fields below to decide whether this recall deserves a deeper report or direct source review.

Recall numberF-0978-2017
Event ID74054
FirmSunset Natural Products Inc.
Firm locationMiami, FL, United States
Initiation dateOctober 13, 2015
Termination dateApril 10, 2017
How to use this recall page

Match the official row against the product in front of you.

Recall rows can be broad. The most important step is comparing the product description, package size, lot/code text, date range, and distribution details against the item or inventory record.

Product description

Colon Therapy, bulk capsules

Lot and code info

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

Distribution pattern

Products distributed to Florida, Nevada and the Dominican Republic

Questions to ask before acting on this recall

Related firm records

Other indexed recalls for Sunset Natural Products Inc.

RecallClassStatusReport dateRecall number
Sunset Natural Products Inc.Oyster Dietary Supplement (unknown container size)Class IITerminatedJanuary 4, 2017F-1033-2017
Sunset Natural Products Inc.DHEA 25 mg, bulk capsulesClass IITerminatedJanuary 4, 2017F-0994-2017
Sunset Natural Products Inc.Colon Therapy, bulk capsulesClass IITerminatedJanuary 4, 2017F-0978-2017
Sunset Natural Products Inc.Argindione, (50,000 capsule bulk)Class IITerminatedJanuary 4, 2017F-0935-2017
Sunset Natural Products Inc.Project #3, 60 capsules per bottleClass IITerminatedJanuary 4, 2017F-0913-2017
Sunset Natural Products Inc.Test Booster, 90 or 60 capsules per bottleClass IITerminatedJanuary 4, 2017F-0916-2017
Sunset Natural Products Inc. Recall Report: Class II Terminated | DataVerityHub