October 2017 FDA Recall Betadine by Purdue Pharma, Lp
D-0070-2018 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Purdue Pharma, Lp on October 5, 2017 for the product Betadine. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0070-2018

Reason for Recall
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Initiated
10-05-2017
Reported
11-15-2017
Quantity
3997 swabsticks

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78229
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.
Purdue Pharma, LP
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01

Batch or Lot Expiration Information

Lot# Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019

Affected Packages Involved in this Recall

67618-153-01 Betadine Solution Swabsticks
67618-153-03 Betadine Solution Swabsticks