Colon Therapy, bulk capsules

FDA recall notice · announced January 4, 2017 · Sunset Natural Products

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Products distributed to Florida, Nevada and the Dominican Republic
Lot/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 # 020514 Exp. Date 05/17, Lot # 030514 Exp. Date 05/17, Lot # 040514 Exp. Date 05/17, Lot # 140514 Exp. Date 06/17, Lot # 150514 Exp. Date 06/17, Lot # 440514 Exp. Date 05/17, Lot # 500514 Exp. Date 05/17, Lot # 510514 Exp. Date 05/17, Lot # 520514 Exp. Date 05/17, Lot # 530514 Exp. Date 05/17, Lot # 540514 Exp. Date 06/17, Lot # 550514 Exp. Date 06/17, Lot # 560514 Exp. Date 06/17, Lot # 570514 Exp. Date 06/17, Lot # 580514 Exp. Date 06/17, Lot # 590514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 600514 Exp. Date 06/17, Lot # 610514 Exp. Date 06/17, Lot # 620514 Exp. Date 07/17, Lot # 020714 Exp. Date 07/17, Lot # 240714 Exp. Date 07/17,Lot # 250714 Exp. Date 07/17, Lot # 260714 Exp. Date 07/17, Lot # 270714 Exp. Date 07/17, Lot # 280714 Exp. Date 07/17, Lot # 290714 Exp. Date 07/17, Lot # 300714 Exp. Date 07/17, Lot # 310714 Exp. Date 08/17, Lot # 320714 Exp. Date 08/17, Lot # 330714 Exp. Date 08/17, Lot # 340714 Exp. Date 08/17, Lot # 350714 Exp. Date 08/17, Lot # 380714 Exp. Date 09/17, Lot # 390714 Exp. Date 09/17, Lot # 400714 Exp. Date 09/17, Lot # 410714 Exp. Date 10/17, Lot # 280814 Exp. Date 10/17, Lot # 290814 Exp. Date 10/17, Lot # 300814 Exp. Date 10/17, Lot # 310814 Exp. Date 10/17, Lot # 320814 Exp. Date 10/17, Lot # 230914 Exp. Date 09/17, Lot # 270914 Exp. Date 10/17, Lot # 081014 Exp. Date 11/17, Lot # 091014 Exp. Date 11/17, Lot # 020615 Exp. Date 07/18, Lot # 040615 Exp. Date 07/18, Lot # 170615 Exp. Date 07/18, Lot # 180615 Exp. Date 08/18, Lot # 390615 Exp. Date 08/18, Lot # 480615 Exp. Date 08/18, Lot # 160715 Exp. Date 07/18
Quantity: 19,455,300
Status: Terminated
Products in this recall event:
- DHEA 25 mg, bulk capsules (F-0994-2017)
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- Liver Energy, 100 capsules per bottle (F-0932-2017)
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- Strev, bulk capsules (F-0987-2017)
- Equs Mas, (30 capsules per bottle) (F-0951-2017)
- Test Booster, 90 or 60 capsules per bottle (F-0916-2017)
- Project #3, 60 capsules per bottle (F-0913-2017)
- Argindione, (50,000 capsule bulk) (F-0935-2017)
- Project #2, 90 capsules per bottle (F-0912-2017)
- Weight Control, 60 capsules per bottle (F-0954-2017)
- Blanc Dietary Supplement (unknown container size) (F-1039-2017)
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- Carni Care, (50,000 capsule bulk) (F-0921-2017)
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- Extra Mega Prostamax Dietary Supplement (unknown container size) (F-1027-2017)
- Glow Dietary Supplement (unknown container size) (F-1080-2017)
- Venocell, bulk capsules (F-1003-2017)
- Moinsage, 60 capsules per bottle (F-0962-2017)
- Bioxtron Dietary Supplement (unknown container size) (F-1024-2017)
- Magic Memory Dietary Supplement (unknown container size) (F-1012-2017)
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- Tevass 2 Dietary Supplement (unknown container size) (F-1064-2017)
- Prostamax Dietary Supplement (unknown container size) (F-1026-2017)
- Super Inmuno Dietary Supplement (unknown container size) (F-1013-2017)
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- Foni, bulk capsules (F-0991-2017)
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- Asey Dietary Supplement (unknown container size) (F-1036-2017)
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- ADAG Dietary Supplement (unknown container size) (F-1065-2017)
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- Aloe Vera, 300 mg, Dietary Supplement (F-1043-2017)
- Collagen 300 mg, bulk capsules (F-1001-2017)
- Chardon De Marie, 60 capsules per bottle (F-0958-2017)
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- Echinacea Dietary Supplement (unknown container size) (F-1049-2017)
- Aloe & L Glutamine Dietary Supplement (unknown container size) (F-1044-2017)
- Prusha, bulk capsules (F-0980-2017)
- Muira Puama, 50 mg, Dietary Supplement (F-1038-2017)
- Vital Cure, 30 capsules per bottle (F-0964-2017)
- Mdrol, 90 capsules per bottle (F-0924-2017)
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- HGH, 100 capsules per bottle (F-0928-2017)
- Horsil, bulk capsules (F-0990-2017)
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- Crea Care, (100,000 capsule bulk) (F-0920-2017)
- Zinc Gluconate, bulk capsules (F-0969-2017)
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- SoMaks, 30 capsules per bottle (F-0911-2017)
- Colon Cleanser Dietary Supplement (unknown container size) (F-1069-2017)
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- Goji Dietary Supplement (unknown container size) (F-1046-2017)
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- Dygeszyme, (50,000 capsule bulk) (F-0936-2017)
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- Kelp Acerola & Green Tea, bulk capsules (F-0988-2017)
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Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.