food · product 1 of 163
Bionix, 30 capsules per bottle
- Recall number
- F-0909-2017
- Initiated
- October 13, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Sunset Natural Products Inc.
- Quantity
- 6,500 Bottles (195,000 capsules)
App-derived interpretation
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.
Inspect official wording and provenance
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.
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 lot and exp date: Lot # 380414 Exp Date 04/17, Lot #310614 Exp Date 07/17, Lot # 391014 Exp Date 12/17
Distribution pattern
Products distributed to Florida, Nevada and the Dominican Republic