The Recall Desk
SevereFDA (Food)·F-0923-2017·Announced 2017-01-04

Sunset Natural Products Recalls Agma Care Dietary Supplement

Sunset Natural Products Inc. is recalling Agma Care dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source metadata explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe).

Plain-English summary

Sunset Natural Products Inc. is recalling Agma Care, a dietary supplement sold in 50,000 capsule bulk containers. The recall is being conducted pursuant to a consent decree entered on September 25, 2015, which prohibits the company and its owners from marketing dietary supplements until specific conditions are met.

The consent decree requires the firm to recall and destroy, under FDA supervision, all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot information includes Lot # 180515 with an expiration date of 05/18.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who possess this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Agma Care, (50,000 capsule bulk)
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
50,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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
  • 2015. Known lot and expiration date: Lot # 180515 Exp. Date 05/18

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 163 recalled by Sunset Natural Products Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 163 products in this recall →

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