FDAFDA · Food and drugs·Recall number F-1050-2017
Nem Dietary Supplement (unknown container size)
Published January 4, 2017 · Recall initiated: October 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Sunset Natural Products Inc.
- Distributor
- Products distributed to Florida, Nevada and the Dominican Republic
- Lot
- 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 lot: Lot # 060315, 180315, 170315, 090515, 180815, 500815, 280615
- Risk classification
- Class II
- Area (FDA)
- food
- Country
- United States
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