FDA-Drug2017-11-15Class II
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Purdue Pharma, LP
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.
Sold states
Nationwide in the USA
Affected count
3997 swabsticks
Manufactured in
1 Stamford Forum, N/A, Stamford, CT, United States
Products
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2018Don't want to check this manually?
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