Class III · Low risk
PVP Scrub Solution (Povidone-Iodine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
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
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04
Affected NDC
53329-0938-04
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Povidone-Iodine NDC 53329-0938 |
.75 g/100mL | Solution Topical |
Medline Industries, LP | OTC |
- Recalling firm
- Medline Industries Inc
- NDC code
- 53329-938-04
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0546-2018 · 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 2018 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
Medline Incision & Drainage Tray
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
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