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Class II: temporary or reversible health riskTerminated

Sunset Natural Products Ramto Recall

Ramto, bulk capsules

Sunset Natural Products Inc. · Miami, FL

Risk level
Class II
Reported by FDA
Jan 4, 2017
Recall ID
F-0992-2017
Check your lot numberHow we source this data

Summary

Sunset Natural Products recalled Ramto starting Oct 13, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0992-2017 on Jan 4, 2017. 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. Status: Terminated.

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.

Product description

Ramto, bulk capsules

Lot numbers, UPCs & expiration codes

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

Products distributed to Florida, Nevada and the Dominican Republic

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0992-2017
Classification
Class II
Status
Terminated
Recall initiated
Oct 13, 2015
FDA report date
Jan 4, 2017
Quantity
9,290,000
Recall type
FDA Mandated
Recalling firm
Sunset Natural Products Inc.

Original FDA data

Every field from FDA enforcement report F-0992-2017, exactly as published.

Show all FDA fields
City
Miami
State
FL
Status
Terminated
Country
United States
Event ID
74054
Address
7345 SW 45th St
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
Postal code
33155-4509
Report date
Jan 4, 2017
Product type
Food
Recall number
F-0992-2017
Classification
Class II
Recalling firm
Sunset Natural Products Inc.
Product quantity
9,290,000
Termination date
Apr 10, 2017
Reason for recall
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.
Voluntary / mandated
FDA Mandated
Product description
Ramto, bulk capsules
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic
Recall initiation date
Oct 13, 2015
Initial firm notification
Letter
Center classification date
Dec 28, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0992-2017, published Jan 4, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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