Sunset Natural Products Inc.

Recall #F-0926-2017 · Initiated 2015-10-13

Plain-language summary

by FoodRecallsDB.info

What happened

Sunset Natural Products Inc. has been ordered by the FDA to recall their Madre Cell dietary supplement due to the company not following required manufacturing safety standards. The company is prohibited from selling dietary supplements until they meet FDA requirements.

Who is at risk

Anyone who purchased Madre Cell capsules distributed in Florida, Nevada, or the Dominican Republic since April 2, 2014 should be concerned.

What to do

If you have this product, stop using it and contact the manufacturer or your retailer for a refund. Check the bottle label to confirm you have Madre Cell with 60 capsules, and note the lot number if available.

Product

Madre Cell, 60 capsules per bottle

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

1000 bottles (60,000 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 # 510315 Exp. Date 04/18, Lot # 410815 Exp. Date 09/18

Voluntary / mandated

FDA Mandated

Initial notification

Letter

Terminated

2017-04-10