D-0546-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 7, 2018
- Initiation Date
- February 15, 2018
- Termination Date
- April 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