D-0546-2018 Class II Terminated
FDA drug recall D-0546-2018 was initiated by Medline Industries Inc on Feb 15, 2018 and is designated Class II. Reason for recall: Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. The recall status is terminated (terminated Apr 29, 2020). Affected quantity: 67,104 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 7, 2018
- Initiation Date
- Feb 15, 2018
- Termination Date
- Apr 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,104 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA and Curacao
Code Information
Lot #: 16EJ0023, Exp 04/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0546-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026