PVP Scrub Solution — Class II drug recall D-0546-2018
Terminated recall by Medline Industries Inc, reported 2018-03-07, distributed nationwide. Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
| Recall number | D-0546-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2018-02-15 |
| Classified | 2018-02-26 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CW |
| Quantity | 67,104 bottles |
| Reason classes | labeling, potency |
| NDC | 53329-0938, 53329-0938-04, 53329-0938-06, 53329-0938-08, 53329-0938-23, 53329-0938-25 |
| Lot numbers | 04/18, 16EJ0023 |
Product
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
Reason for recall
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0546-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.