D-0273-2018 Class II Terminated
FDA drug recall D-0273-2018 was initiated by Medline Industries Inc on Sep 21, 2017 and is designated Class II. Reason for recall: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. The recall status is terminated (terminated Aug 28, 2023). Affected quantity: 280 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 7, 2018
- Initiation Date
- Sep 21, 2017
- Termination Date
- Aug 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 cases
Product Description
Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Reason for Recall
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Distribution Pattern
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Code Information
Pack Number: DYNDC2282; Lots: 16CB5897; 16PB9981
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0273-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026