Drug product
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
D-0070-2018
Product summary
- Event
- Event 78229
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3997 swabsticks
- Official record key
drug-enforcement:D-0070-2018
Official wording
Reason: 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.
Code information: Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent