Home / Recalls / Sunset Natural Products Inc. / F-0981-2017

F-0981-2017 Class II Terminated

Recalled by Sunset Natural Products Inc. — Miami, FL

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
2,040,000 capsules

Product Description

Memory, 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.

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 # 460514 Exp. Date 06/17, Lot # 160814 Exp. Date 08/17, Lot # 060215 Exp. Date 02/18, Lot # 070215 Exp. Date 02/18, Lot # 010515 Exp. Date 06/18, Lot # 270615 Exp. Date 08/18, Lot # 020815 Exp. Date 08/18

Other recalls by Sunset Natural Products Inc.

  • F-0996-2017 Class II — Resin, bulk capsules (October 13, 2015)
  • F-0975-2017 Class II — Bima, bulk capsules (October 13, 2015)
  • F-1041-2017 Class II — Marx Dietary Supplement (unknown container size) (October 13, 2015)
  • F-1046-2017 Class II — Goji Dietary Supplement (unknown container size) (October 13, 2015)
  • F-0953-2017 Class II — ABS Reducer, 60 capsules per bottle (October 13, 2015)
  • F-1000-2017 Class II — Pritos, bulk capsules (October 13, 2015)
  • F-1032-2017 Class II — Proga Dietary Supplement (unknown container size) (October 13, 2015)
  • F-0993-2017 Class II — Abte, bulk capsules (October 13, 2015)
  • F-0920-2017 Class II — Crea Care, (100,000 capsule bulk) (October 13, 2015)
  • F-0989-2017 Class II — Bees, bulk capsules (October 13, 2015)