Well at Walgreens Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30. The product is a 0.7 OZ (19.8 g) tube distributed by Walgreen Co. The specific lot number is 163241K, with an expiration date of October 2018. The product was distributed nationwide in the USA.
The recall was initiated because the product failed to meet specification requirements 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 issue.
Consumers who have this 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
- Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Topical Sunscreen
- Hazard
- Affected units
- 6,516
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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