Reported Nov 15, 2017 · Terminated

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

Purdue Pharma, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Purdue Pharma, LP · 1 Stamford Forum · Stamford, CT · 06901-3516

Is this the product you have?

  • Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist
  • byPurdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Lot codes and dates
  • Lots
    • 62823 Exp. 12/31/18
    • 64304 Exp. 05/31/2019
    • 64711 Exp. 08/31/2019
    • 65915 Exp. 12/31/2019
Amount recalled
3997 swabsticks

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 24, 2020 · Data as of Sep 19, 7:53 PM UTC

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