The Recall Desk
SevereFDA (Food)·F-0933-2017·Announced 2017-01-04

Sunset Natural Products Recalls Artrosamin Dietary Supplement Capsules

Sunset Natural Products Inc. is recalling Artrosamin capsules pursuant to a consent decree requiring the destruction of supplements 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 agency classification is FDA Class II, which corresponds to a score of 4 (Severe) per the rubric, as it involves a significant health risk or temporary/reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Artrosamin, a dietary supplement available in bulk orders of 250,000 capsules. The recall covers a total of 3,000,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic.

This recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy all supplements manufactured or distributed since April 2, 2014. The decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. The decree was entered on September 25, 2015.

Known lots include those with expiration dates of 04/17 and 05/17. Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA.

The recalled product

Product
Artrosamin, 250,000 capsules per bulk order
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
3,000,000

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 (20)

  • 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 lots and expiration dates: Lot # 030414 Exp. Date 04/17
  • Lot # 040414 Exp. Date 04/17
  • Lot # 050414 Exp. Date 04/17
  • Lot # 060414 Exp. Date 04/17
  • Lot # 070414 Exp. Date 04/17
  • Lot # 080414 Exp. Date 04/17
  • Lot # 010514 Exp. Date 04/17
  • Lot # 080514 Exp. Date 04/17
  • Lot # 090514 Exp. Date 04/17
  • Lot # 100514 Exp. Date 05/17

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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