Drug recall D-0070-2018
Product
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
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.
Lots and codes
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
Recall details
- Recalling firm
- Purdue Pharma, LP, Stamford, CT
- Quantity
- 3997 swabsticks
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 5, 2017
- Terminated
- January 24, 2020
Related products
- Betadine – drug information
- NDC 67618-153 Betadine Solution Swabsticks · Povidone-iodine 10 mg/mL · Atlantis Consumer Healthcare, Inc.