Vertra Sunscreen Recalled for Manufacturing Quality Deviations
EAI-JR286 Inc. is recalling 5,355 tubes of Vertra Elemental Resistance Sunscreen due to manufacturing deviations that may impact product quality.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported and the hazard is related to manufacturing quality (viscosity) rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
EAI-JR286 Inc. is recalling 5,355 tubes of Vertra Elemental Resistance Sun Protection Cream, SPF 50+. The product is distributed nationwide in the USA and Puerto Rico. The recall involves Lot # 609124 with an expiration date of 03/18.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured in a manner that may impact product quality, including failed viscosity tests. The source text does not report any illnesses or injuries associated with this recall.
Consumers who have this product should stop using it and contact the distributor for further instructions or a refund.
The recalled product
- Product
- Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC…
- Manufacturer
- EAI-JR286 INC
- Category
- Drug — Sunscreen
- Affected units
- 5,355
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 (1)
- Lot #: 609124
Distribution
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