February 2018 FDA Recall Scrub by Medline Industries Inc
D-0546-2018 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Medline Industries Inc on February 15, 2018 for the product Scrub. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0546-2018
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
02-15-2018
03-07-2018
67,104 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medline Industries Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Curacao
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
