Product description
Kelp Acerola & Green Tea, bulk capsules
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.
View full record
- Event ID
- 74054
- 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 # 170614 Exp. Date 08/17, Lot # 200515 Exp. Date 06/18
- Product quantity
- 330,000 capsules
- Distribution pattern
- Products distributed to Florida, Nevada and the Dominican Republic
- Voluntary / mandated
- FDA Mandated
- Initial firm notification
- Letter
- Product type
- Food
- Recalling firm location
- 7345 SW 45th St, N/A, Miami, FL, United States
- Recall initiation date
- 10/13/2015
- Center classification date
- 12/28/2016
- Termination date
- 04/10/2017