Class II
Terminated
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
- Company
- Purdue Pharma L.P.
- Recall Initiated
- October 5, 2017
- Posted
- November 15, 2017
- Recall Number
- D-0070-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3997 swabsticks
- Firm Location
- Stamford, CT, United States
Reason for Recall
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
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