The Recall Desk
SevereFDA (Food)·F-0929-2017·Announced 2017-01-04

Sunset Natural Products Recalls Collagen and Vitamin C Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Collagen & VIT C 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 Severe rating (score 4) under the rubric, particularly given the mandatory destruction of products under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling 23,100 bottles of Collagen & VIT C, 60 capsules per bottle. The 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 dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry on September 25, 2015.

The decree requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. The affected products were distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the agency's recall documentation.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction or return of the product.

The recalled product

Product
Collagen & VIT C, 60 capsules per bottle
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard

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 (19)

  • 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 # 160415 Exp. Date 04/18
  • Lot # 270415 Exp. Date 04/18
  • Lot # 280415 Exp. Date 06/18
  • Lot # 290415 Exp. Date 05/18
  • Lot # 550615 Exp. Date 06/18
  • Lot # 560615 Exp. Date 07/18
  • Lot # 530814 Exp. Date 09/17
  • Lot # 120115 Exp. Date 01/17
  • Lot # 360515 Exp. Date 06/18

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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