The Recall Desk
ModerateFDA (Food)·F-1002-2017·Announced 2017-01-04

Sunset Natural Products Recalls Garcam Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Garcam bulk capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary action mandated by a consent decree to ensure compliance with cGMP standards. No specific health hazards, illnesses, or injuries are reported in the source text.

Plain-English summary

Sunset Natural Products Inc. is recalling Garcam bulk capsules. The recall is being conducted pursuant to a consent decree that 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 all dietary supplements that were manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The source text does not specify a particular health hazard, illness, or injury associated with this product. Consumers should stop using the recalled Garcam bulk capsules and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the product.

The recalled product

Product
Garcam, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
60,000

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 # 260814 Exp. Date 08/17

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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