Food recall

Sunset Natural Products Inc. recall: Abee Med

Sunset Natural Products Inc., of Miami, FL, recalled Abee Med and 9 other products. The FDA's 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...” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall on October 5, 2015, and the FDA first listed it in its Enforcement Report of February 24, 2016. The FDA ordered the recall. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed April 10, 2017

The recall

Company
Sunset Natural Products Inc. (Miami, FL)
Reason, in FDA's words
“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 manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.”
Where it was sold
FL and NV
Recall began
, ordered by the FDA
FDA classified it
First in an FDA Enforcement Report
FDA event number
72877

The 10 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0536-2016 Class II

    Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products

    Codes: Lot # 420415 Exp. Date 04/18 UPC 850993004017

    Quantity: 3,149 bottles (240,000 caps)

  • F-0537-2016 Class II

    Argindione, sold as bulk of 50,000 capsules.

    Codes: Lot # 480514 Exp. Date 05/17 and Lot # 320614 Exp. Date 06/17

    Quantity: 100,000 capsules

  • F-0538-2016 Class II

    Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products

    Codes: Lot # 141214 Exp. Date 12/17 UPC 897666001157

    Quantity: 3,260 bottles (200,000 caps)

  • F-0539-2016 Class II

    Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products

    Codes: Lot # 030615 Exp. Date 07/18 UPC 897666001164

    Quantity: 5,000 bottles (300,000 caps)

  • F-0540-2016 Class II

    Neuro-Cetin, sold in bulk 50,000 capsules.

    Codes: Lot # 110315 Exp. Date 04/18

    Quantity: 50,000 capsules

  • F-0541-2016 Class II

    Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products

    Codes: Lot # 180215 Exp Date 02/18 UPC 897666001144,

    Quantity: 5000 bottles (300,000)

  • F-0542-2016 Class II

    Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products

    Codes: Lot # 140515 Exp. Date 05/18 UPC 850993004055,

    Quantity: 4,000 bottles (240,000 capsules)

  • F-0543-2016 Class II

    Prostax Forte, sold in bulk of 50,000 capsules.

    Codes: Lot # 120315 Exp. Date 03/18

    Quantity: 50,000 capsules

  • F-0544-2016 Class II

    Venocell, sold in bulk of 50,000 capsules.

    Codes: Lot # 160614 Exp. Date 06/17 and Lot # 490914 Exp. Date 10/17

    Quantity: 100,000 capsules

  • F-0617-2016 Class II

    Hepasil, sold in bulk of 500,000 capsules.

    Codes: Lot # 080315 Exp. Date 03/18

    Quantity: 500,000 capsules

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of February 24, 2016.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.