February 2016 FDA Recall Scrub-stat by Ecolab Inc
D-0766-2016 - Subpotent drug
This Class III drug recall was voluntarily initiated by Ecolab Inc on February 12, 2016 for the product Scrub-stat. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0766-2016
Subpotent drug
02-12-2016
03-16-2016
706 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Ecolab 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, Puerto Rico and Canada
03-24-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102
Batch or Lot Expiration Information
Lot# : a) L041051, Exp 04 /17; L060151, L061951, Exp 06 /17; b) L060151, L061951, Exp 06 /17
