FDAFDA · Food and drugs·Recall number D-0070-2018
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Published November 15, 2017 · Recall initiated: October 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BETADINE
- Manufacturer
- Purdue Pharma, LP
- Distributor
- Nationwide in the USA
- Lot
- Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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