Ramto, 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

Ramto, bulk capsules

Quantity: 9,290,000

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 # 430614 Exp. Date 06/17, Lot # 440614 Exp. Date 06/17, Lot # 460614 Exp. Date 07/17, Lot # 470614 Exp. Date 07/17, Lot # 480614 Exp. Date 07/17, Lot # 500614 Exp. Date 07/17, Lot # 510614 Exp. Date 07/17, Lot # 520614 Exp. Date 07/17, Lot # 530614 Exp. Date 07/17, Lot # 540614 Exp. Date 07/17, Lot # 550614 Exp. Date 07/17, Lot # 560614 Exp. Date 07/17, Lot # 055714 Exp. Date 08/17, Lot # 060714 Exp. Date 08/17, Lot # 070714 Exp. Date 08/17, Lot # 080714 Exp. Date 08/17, Lot # 470914 Exp. Date 10/17, Lot # 550914 Exp. Date 10/17, Lot # 380115 Exp. Date 02/18, Lot # 190315 Exp. Date 03/18, Lot # 200315 Exp. Date 03/18

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-0992-2017 · 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

Ramto, 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