Agency classClass IIOur severity:Moderate FDA (Drugs)·D-225-2013·Announced 2013-04-03

CareFusion Recalls SEPP 2% Iodine Tincture Applicators for Sterility Mislabeling

CareFusion 213, LLC is recalling SEPP 2% Iodine Tincture applicators because the product is not sterile, making the labeling misleading regarding sterility claims.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding sterility claims rather than a confirmed contamination or injury event.

Plain-English summary

CareFusion 213, LLC is voluntarily recalling approximately 3,032,000 applicators of SEPP 2% Iodine Tincture USP. The product is packaged in 200-count and 3000-count applicators and is distributed nationwide, as well as in Puerto Rico, the Virgin Islands, Malaysia, and the United Kingdom.

The recall is due to a labeling issue where the product is misbranded because it is not sterile, yet the labeling is misleading in relation to sterility claims. The affected lots include all lots with expiry dates between 02/12 and 10/15, 09/11 and 12/13, and 12/11 and 12/11.

Consumers and healthcare facilities should stop using the affected product and contact CareFusion 213, LLC for further instructions or a refund.

The recalled product

Product: SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net…
Manufacturer: CareFusion 213, LLC
Category: Drug — Topical Antiseptic
Hazard: mis-labeling
sterility-claim
Affected units: 3,032,000

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 (3)

a) All lots with expiry between 02/12 to 10/15
b) All lots with expiry between 09/11 to 12/13
and c) All lots with expiry between 12/11 to 12/11.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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 →

Same manufacturer · CareFusion 213, LLC

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Same hazard · mis labeling