FDAClass IIFebruary 7, 2018

Aplicare Povidone-Iodine Prep Pad recall: Subpotent

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

Why was Aplicare Povidone-Iodine Prep Pad recalled?

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

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?

Part # P-1001; Lots: 58471; 59003; 59723; 60373; 60807; 61187; 61523; 61998; 63974; 64701; 65864 Part # P-1001-8S Lots: 58368; 58371; 58472; 58499; 58686; 58687; 58688; 58816; 58817; 58818; 59002; 59004; 59333; 59334; 59335; 59574; 59724; 59725; 60157; 60237; 60374; 60375; 60507; 60586; 61101; 61368; 61427; 61618; 61750; 61751; 61999; 62067; 62224; 62226; 62557; 62558; 62954; 62955; 63441; 63442; 63443; 63507; 63508; 64002; 64129; 64243; 64245; 64592; 64840; 65081; 65327; 65583; 65681; 65882; 66026; 66040; 66110; 66193; Part # P-1011 Lots: 66549; 66916 Part # P-1011-8S Lots: 66404; 66580; 66622; 66709; 66856

Product
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA.…
Recalling firm
Medline Industries Inc
Quantity
11,750 cases
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls