SEPP 10% Povidone Iodine Solution USP recall: Sterility Concern
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.
Why was SEPP 10% Povidone Iodine Solution USP 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?
a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.
- 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.
- Recalling firm
- CareFusion 213, LLC
- Quantity
- 8,960,000 applicators
- Distribution
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Recall date
- April 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)