Recall Number: F-0999-2017
Why was Maca 250 mg, bulk capsules recalled?
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.
Check out this page for guidance on what to do if you've consumed food from recall F-0999-2017 .
City: Miami
State: Florida
Country: United States
Classification: Class II
Classification Date: 2016-12-28
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.
Product Description: Maca 250 mg, bulk capsules
Report Date: 2017-01-04
Product Type: Food
Company: Sunset Natural Products Inc.
Status: Terminated
Recall Number: F-0999-2017
Postal Code: 33155-4509
Recall Initiation Date: 2015-10-13
Recall End Date: 2017-04-10
Event ID: 74054
Distribution Pattern: Products distributed to Florida, Nevada and the Dominican Republic
Voluntary Or Mandated: FDA Mandated
Initial Firm Notification: Letter
Extra 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 # 190814 Exp. Date 08/17, Lot # 030115 Exp. Date 02/18, Lot # 190415 Exp. Date 06/18
Product Quantity: 270,000
Address: 7345 SW 45th St
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