Food product
Gludo, bulk capsules
F-0986-2017
Product summary
- Event
- Event 74054
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,530,000
- Official record key
food-enforcement:F-0986-2017
Official wording
Reason: 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 lots and expiration dates: Lot # 030614 Exp. Date 07/17, Lot # 460814 Exp. Date 09/17, Lot # 080914 Exp. Date 10/17, Lot # 090914 Exp. Date 10/17, Lot # 021114 Exp. Date 11/17, Lot # 050115 Exp. Date 02/18, Lot # 030415 Exp. Date 05/18
Distribution pattern: Products distributed to Florida, Nevada and the Dominican Republic
Derived failure modes
-
Unknown
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.