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…
Horny Goat Weed 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
Horny Goat Weed, bulk capsules
Quantity: 1,100,000
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 # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
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-0974-2017 · 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.
Performens
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…
SoMaks
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…
Project #2
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…
Project #3
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…
Nutra Pro
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…
Oxy Extreme
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…
Test Booster
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…
Fat Burner
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…
Thor, 60 capsules per bottle
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…
Night Stallion (80
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…
Crea Care (100
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…
Showing 12 of 162.
Other recalls by Sunset Natural Products Inc.
Hepasil sold in bulk of 500
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 manufatured or…
Venocell sold in bulk of 50
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 manufatured or…
Prostax Forte sold in bulk of 50
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 manufatured or…
Prostamax DUO
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 manufatured or…