FDA Drug recall D-226-2013
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.6…
- FDA Drug
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.6… by Carefusion 213, citing labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-226-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-04 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Carefusion 213 |
| Distribution | US |
Product
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS 66211.
Reason
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Identifiers
| code_info | a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-226-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.