Cicatricure Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling Cicatricure Scar Cream + Sunscreen SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Product Quest Manufacturing LLC is recalling 7,944 tubes of Cicatricure, Scar Cream + Sunscreen SPF 30. The product is distributed by Genomma Lab USA Inc. and was sold nationwide in the USA. The specific lot affected is 163241K, with an expiration date of October 2018.
The recall was initiated because the product failed to meet specification standards for its active ingredients. Specifically, assay results indicated that the levels of octocrylene and avobenzone were lower than the required amounts. This is classified as a subpotent drug recall.
Consumers who have this specific product should stop using it and return it to the place of purchase for a refund or follow instructions from the recalling firm. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Topical Sunscreen
- Hazard
- Affected units
- 7,944
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: 163241K
- Exp. October 2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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