CLASS II Drug recall · Reported 7 Mar 2018 · FDA Enforcement Report
PVP Scrub Solution, Povidone Iodine recalled by Medline Industries
Medline Industries is recalling PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), distributed nationwide in the US. The recall was initiated on 15 Feb 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0546-2018
- FDA event ID
- 79267
- Recalling firm
- Medline Industries, Northfield, IL
- Brand
- Povidone-iodine
- Manufacturer
- Medline Industries, LP
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2018
- FDA classified
- 26 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Feb 2018 | Recall initiated by company | |
| 26 Feb 2018 | Classified by FDA | +11 days |
| 7 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA and Curacao
Questions about this recall
Why was it recalled?
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Which lots are affected?
Lot #: 16EJ0023, Exp 04/18
Where was it sold?
Nationwide in the USA and Curacao
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medline Industries
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Packaging Defects | Nationwide |
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Other Povidone-iodine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one | Elevate Oral Care | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |