August 2017 FDA Recall Drug by Degasa Sa De Cv
D-1129-2017 - Labeling

This Class II drug recall was voluntarily initiated by Degasa Sa De Cv on August 4, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in CA, IL. and the recall is currently terminated.

Recall Number: D-1129-2017

Reason for Recall
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Initiated
08-04-2017
Reported
09-13-2017
Quantity
720 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78034
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Degasa Sa De Cv
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, IL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-24-2020
Product Description About Product Description
Full technical description of the product.
Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09

Batch or Lot Expiration Information

Lot# : 3A176011, Exp 10/18