F-0939-2017 Class II Terminated
Recall Details
- Product Type
- Food
- Report Date
- January 4, 2017
- Initiation Date
- October 13, 2015
- Termination Date
- April 10, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 900 Bottles (27,000 capsules)
Product Description
Magnun Plus, (30 per bottle)
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 Pattern
Products distributed to Florida, Nevada and the Dominican Republic
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 # 210514 Exp. Date 05/17, Lot # 050315 Exp. Date 03/18