FDA Drug Class II — Moderate

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01

Hazard

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.

Products

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Brand
Purdue Pharma, LP
UPC
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019

Units Affected

3997 swabsticks