D-0070-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 15, 2017
- Initiation Date
- October 5, 2017
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3997 swabsticks
Product Description
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019