PlainRecalls
FDA Drug Moderate Class II Terminated

Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1

Reported: February 7, 2018 Initiated: September 21, 2017 #D-0252-2018

Product Description

Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1

Reason for Recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Details

Recalling Firm
Medline Industries Inc
Units Affected
11,750 cases
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1. Recalled by Medline Industries Inc. Units affected: 11,750 cases.
Why was this product recalled?
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2018. Severity: Moderate. Recall number: D-0252-2018.