Food product
Horny Goat Weed, bulk capsules
F-0974-2017
Product summary
- Event
- Event 74054
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,100,000
- Official record key
food-enforcement:F-0974-2017
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 # 320414 Exp. Date 05/17, Lot # 590614 Exp. Date 07/17, Lot # 510814 Exp. Date 09/17, Lot # 210914 Exp. Date 09/17, Lot # 540914 Exp. Date 10/17, Lot # 570914 Exp. Date 10/17, Lot # 151014 Exp. Date 11/17, Lot # 350215 Exp. Date 03/18, Lot # 350415 Exp. Date 05/18, Lot # 020115 Exp. Date 01/18
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.