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.
The agency’s classification
FDA (Drugs): 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 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
- Manufacturer
- Genesis Pharmaceutical, Inc.
- Category
- Drug — Topical Acne Treatment
- Hazard
- 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.
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