Abte, bulk capsules
This recall has been terminated (originally issued January 4, 2017).
- Company
- Sunset Natural Products Inc.
- Recall Initiated
- October 13, 2015
- Posted
- January 4, 2017
- Recall Number
- F-0993-2017
- Voluntary / Mandated
- FDA Mandated
- Quantity
- 60,000 capsules
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
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.
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 # 040714 Exp. Date 07/17