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Class II

Sunset Natural Products Inc.

Recall #F-0979-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info
What happened
Sunset Natural Products Inc. is recalling Haga bulk capsules due to a court order requiring the company to stop selling dietary supplements and recall products made since April 2, 2014, until they meet FDA safety standards. About 70,000 capsules were distributed to Florida, Nevada, and the Dominican Republic.
Who is at risk
Anyone who purchased Haga bulk capsules from this company should be concerned, as the recall applies to all products distributed during this time period.
What to do
If you have Haga bulk capsules from Sunset Natural Products Inc., stop using them and contact the company or your retailer for instructions on return or disposal. Check your purchases if you live in Florida or Nevada, or verify the product source if you're in the Dominican Republic.
Product
Haga, bulk capsules
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
70,000 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 lots and expiration dates: Lot # 330514 Exp. Date 06/17, Lot # 420614 Exp. Date 06/17
Voluntary / mandated
FDA Mandated
Initial notification
Letter
Terminated
2017-04-10

Recalling firm

Sunset Natural Products Inc.
7345 SW 45th St
Miami, FL 33155-4509
United States

Recall classification

Remote probability of serious adverse health consequences, or temporary reversible consequences.

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