FDA Drug recall D-0257-2018
Medline Newborn Kit
- FDA Drug
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Medline Newborn Kit by Medline Industries, citing subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0257-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-21 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Identifiers
| code_info | Pack Number: DYKL1133; Lots: 17IA0348; 17GA0975; 17IA0348 |
|---|
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-0257-2018%22
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