Recalls / Class II
Class IIF-0992-2017
Product
Ramto, bulk capsules
- Type
- Food
- Affected lot / 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 # 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
- Quantity
- 9,290,000
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.
Recalling firm
- Firm
- Sunset Natural Products Inc.
- Notification channel
- Letter
- Type
- FDA Mandated
- Address
- 7345 SW 45th St, N/A, Miami, Florida 33155-4509
Distribution
- Distribution pattern
- Products distributed to Florida, Nevada and the Dominican Republic
Timeline
- Recall initiated
- 2015-10-13
- FDA classified
- 2016-12-28
- Posted by FDA
- 2017-01-04
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0992-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.