Purdue Pharma, LP recalls Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 6
Recalled November 15, 2017 · FDA recall D-0070-2018 · Purdue Pharma
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. · FDA Class II
Units
3997 swabsticks
Sold at
Nationwide in the USA
Description
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.
Product
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Manufacturer(s)
Purdue Pharma, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →