FDAClass IIApril 3, 2013

SEPP 70% Isopropanol recall: Sterility Concern

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…

Why was SEPP 70% Isopropanol recalled?

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots distributed between 01/10 to 02/13

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…
Recalling firm
CareFusion 213, LLC
Quantity
698,000 applicators
Distribution
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Recall date
April 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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