PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: April 3, 2013 Initiated: March 4, 2013 #D-224-2013

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
CareFusion 213, LLC
Units Affected
698,000 applicators
Distribution
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by CareFusion 213, LLC. Units affected: 698,000 applicators.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 3, 2013. Severity: Moderate. Recall number: D-224-2013.