CLASS II Drug recall · Reported 3 Apr 2013 · FDA Enforcement Report
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v recalled
CareFusion 213 is recalling SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP applicators (net each) per, distributed nationwide in the US. The recall was initiated on 4 Mar 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-224-2013
- FDA event ID
- 64583
- Recalling firm
- CareFusion 213, El Paso, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2013
- FDA classified
- 28 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 4 Mar 2013 | Recall initiated by company | |
| 28 Mar 2013 | Classified by FDA | +24 days |
| 3 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Questions about this recall
Why was it 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 lots are affected?
All lots distributed between 01/10 to 02/13
Where was it sold?
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 64583This product is part of a recall event; the main page for the event is SEPP 10% Povidone Iodine Solution USP (1% available Iodine recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SEPP 10% Povidone Iodine Solution USP (1% available Iodine recalled | CareFusion 213 | Labeling Errors | Nationwide | |
| CLASS II | Donor Prep Kit containing 1 Frepp (70% isopropyl alcohol) recalled | CareFusion 213 | Labeling Errors | Nationwide | |
| CLASS II | Frepp/Sepp Kit containing 1 Frepp recalled by CareFusion 213 | CareFusion 213 | Labeling Errors | Nationwide | |
| CLASS II | SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol recalled | CareFusion 213 | Labeling Errors | Nationwide | |
| CLASS II | Blood Culture Prep Kit II containing 1 Frepp recalled by CareFusion 213 | CareFusion 213 | Labeling Errors | Nationwide |
More recalls from CareFusion 213
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |