Class III · Low risk
Aplicare Povidone-Iodine Prep Pad
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What 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
Affected NDC
52380-0111-01
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
- Recalling firm
- Medline Industries Inc
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0252-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iodine recalls
See all
Class I · High risk
Optiray Imaging Bulk Package-350
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Class II · Moderate risk
BD PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
Povi-One
sub potency
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Other recalls by Medline Industries Inc
All 2017 recalls
Class II · Moderate risk
Hand Sanitizer Foam
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class III · Low risk
Readyprep Chg
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class II · Moderate risk
SparkleFresh Fluoride Toothpaste
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
PVP Scrub Solution
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
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