The Recall Desk
Agency classClass IIIOur severity:LowFDA (Food)·F-0105-2017·Announced 2016-10-26

Triceutical Inc. Recalls Lecithin Soft Gels Due to Manufacturing Deficiencies

Triceutical Inc. is recalling all lecithin soft gels because they were not produced under good manufacturing practices. The recall covers 714 bottles distributed in Florida, New York, Pennsylvania, and China.

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a lack of good manufacturing practices without reported illness.

Plain-English summary

Triceutical Inc. has initiated a recall of all lecithin soft gels. The company identified that the products were not manufactured in accordance with good manufacturing practices (GMP). This recall includes 714 bottles of the dietary supplement.

The affected products were distributed domestically in Florida, New York, and Pennsylvania, as well as internationally in China. The recall covers all lot numbers and all expiration dates for this specific product.

Consumers who have purchased these lecithin soft gels should stop using them and contact the manufacturer for further instructions or a refund. The recall is classified as Class III by the FDA, indicating that the violation is unlikely to cause adverse health consequences.

The recalled product

Product
Lecithin soft gels
Manufacturer
Triceutical Inc./Zhang
Category
Food — Dietary Supplement
Hazard
Affected units
714

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 (2)

  • all lot numbers
  • all expiration dates

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 21 recalled by Triceutical Inc./Zhang 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 21 products in this recall →

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