Povidone-iodine Solution
FDA Recall NDC 53329-938
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Povidone-iodine (NDC 53329-938). A significant event, classified as Class II, was initiated on Feb 15, 2018 by Medline Industries, Lp. The reported reason for this action was: "Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Feb 15, 2018
Mar 07, 2018
67,104 bottles
Recall Profile & Regulatory Data
Event ID
79267
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Medline Industries Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Curacao
Termination Date
Apr 29, 2020
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
Batch or Lot Expiration Information
Lot# : 16EJ0023, Exp 04/18
Affected Packages Involved in this Recall
53329-938-06Product
53329-938-08Product
53329-938-23Product
53329-938-25Product
53329-938-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
