The Recall Desk
LowFDA (Drugs)·D-1285-2014·Announced 2014-05-07

Glytone Acne Facial Cleanser Recalled for Viscosity Specification Failure

Genesis Pharmaceuticals is recalling 461 bottles of Glytone Acne Treatment Facial Cleanser due to out-of-specification viscosity results.

What this means for you

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 specific defect is a viscosity failure, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Genesis Pharmaceuticals, Inc. is recalling 461 bottles of Glytone Acne Treatment Facial Cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz. The affected product is identified by Lot 54 with an expiration date of 1/14/2016. The recall was initiated because the product failed stability specifications, specifically showing out-of-specification results for viscosity in one lot.

The product was distributed nationwide. The recall is classified as Class III by the U.S. Food and Drug Administration, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and may contact the recalling firm for further information or a refund.

The recalled product

Product
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
Affected units
461

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)

  • Lot 54
  • Exp: 1/14/2016

Distribution

Distributed nationwide across the United States.