FDA Drug recall D-0546-2018
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries…
- FDA Drug
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries… by Medline Industries, citing subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0546-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-15 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medline Industries |
| Distribution | US |
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
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Identifiers
| ndc | 53329-938-06 |
|---|---|
| ndc | 53329-938-08 |
| ndc | 53329-938-23 |
| ndc | 53329-938-25 |
| ndc | 53329-938-04 |
| code_info | Lot #: 16EJ0023, Exp 04/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.