Purdue Pharma, LP recalls Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC…

Recall date

October 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0070-2018

FDA classification

Class II

Brand / firm

Purdue Pharma, LP

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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