Recalls / Class II

Class IIF-0971-2017

Product

Aloe Vera 500 mg, bulk capsules

Type

Food

Affected lot / 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 # 170414 Exp. Date 05/17, Lot # 260414 Exp. Date 05/17, Lot # 270414 Exp. Date 05/17, Lot # 430414 Exp. Date 05/17, Lot # 440414 Exp. Date 07/17, Lot # 450414 Exp. Date 06/17, Lot # 170514 Exp. Date 06/17, Lot # 180514 Exp. Date 06/17, Lot # 340514 Exp. Date 08/17, Lot # 350514 Exp. Date 08/17, Lot # 360514 Exp. Date 09/17, Lot # 370514 Exp. Date 08/17, Lot # 050814 Exp. Date 09/17, Lot # 060814 Exp. Date 10/17, Lot # 070814 Exp. Date 10/17, Lot # 080814 Exp. Date 10/17, Lot # 030914 Exp. Date 10/17, Lot # 040914 Exp. Date 10/17, Lot # 050914 Exp. Date 10/17, Lot # 060914 Exp. Date 10/17, Lot # 190914 Exp. Date 09/17, Lot # 220914 Exp. Date 09/17, Lot # 240914 Exp. Date 09/17, Lot # 380914 Exp. Date 10/17, Lot # 390914 Exp. Date 11/17, Lot # 400914 Exp. Date 11/17, Lot # 410914 Exp. Date 11/17, Lot # 501014 Exp. Date 11/17, Lot # 511014 Exp. Date 11/17, Lot # 521014 Exp. Date 11/17, Lot # 531014 Exp. Date 11/17

Quantity

12,310,000 capsules

Why it was 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.

Recalling firm

Firm

Sunset Natural Products Inc.

Notification channel

Letter

Type

FDA Mandated

Address

7345 SW 45th St, N/A, Miami, Florida 33155-4509

Distribution

Distribution pattern

Products distributed to Florida, Nevada and the Dominican Republic

Timeline

Recall initiated

2015-10-13

FDA classified

2016-12-28

Posted by FDA

2017-01-04

Terminated

2017-04-10

Status

Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0971-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.