CareFusion Recalls Misbranded Isopropanol Applicators Due to Sterility Labeling
CareFusion 213, LLC is recalling 698,000 SEPP 70% Isopropanol applicators because the product is not sterile, making the labeling misleading regarding sterility claims.
What this means for you
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 due to a labeling error regarding sterility claims. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
CareFusion 213, LLC is voluntarily recalling 698,000 applicators of SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP. The product is identified by Catalog No. 260201 and NDC 54365-170-01. The recall involves 200-count cartons containing applicators with a net volume of 0.67 mL each.
The FDA has classified this recall as Class II. The product is considered misbranded because it is not sterile, yet the labeling is misleading in relation to sterility claims. This labeling error could lead users to believe the product is sterile when it is not.
The affected lots were distributed between January 10 and February 13. Distribution was nationwide, including Puerto Rico, the Virgin Islands, Malaysia, and the United Kingdom. Consumers and healthcare providers should stop using the product and contact CareFusion 213, LLC for further instructions or a refund.
The recalled product
- Product
- SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 698,000
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)
- All lots distributed between 01/10 to 02/13
Distribution
Part of a larger recall action
This product is one of 6 recalled by CareFusion 213, 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.
See all 6 products in this recall →Related recalls
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