RLRecall Lot Watch
Recall profile

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

Sunset Natural Products Inc. recall for DHEA 25 mg, 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

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Recall numberF-0994-2017
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

DHEA 25 mg, 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 # 140714 Exp. Date 08/17, Lot # 310914 Exp. Date 10/17, Lot # 560914 Exp. Date 10/17, Lot # 271214 Exp. Date 12/17, Lot # 070115 Exp. Date 01/18, Lot # 460315 Exp. Date 04/18, Lot # 080615 Exp. Date 08/18

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