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Recall Observatory FDA recall evidence

Food product

Ramto, bulk capsules

F-0992-2017

October 13, 2015

Class II

Product summary

Firm
Sunset Natural Products Inc.
Event
Event 74054
Status
Terminated
Classification
Class II
Quantity
9,290,000
Official record key
food-enforcement:F-0992-2017

Official wording

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 expert and receive written permission from FDA to resume operations.

Code information: 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

Distribution pattern: Products distributed to Florida, Nevada and the Dominican Republic

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.