Sunset Natural Products Inc.

Recall #F-0921-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info

What happened

The FDA ordered Sunset Natural Products Inc. to recall Carni Care dietary supplement capsules because the company violated manufacturing and safety regulations. The company is prohibited from selling dietary supplements until it meets specific requirements, including hiring a quality expert and getting FDA approval to restart operations.

Who is at risk

Anyone who purchased Carni Care capsules distributed in Florida, Nevada, or the Dominican Republic since April 2, 2014 should be aware of this recall.

What to do

If you have this product, stop using it and contact Sunset Natural Products Inc. or the FDA for instructions on returning it. Check your supplements to see if you have this brand and product, especially if purchased in the affected states.

Product

Carni Care, (50,000 capsule bulk)

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.

Quantity affected

50,000 capsules

Distribution

Products distributed to Florida, Nevada and the Dominican Republic

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 lot and expiration date: Lot # 410415 Exp. Date 04/18

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10