D-0070-2018 Class II Terminated
FDA drug recall D-0070-2018 was initiated by Purdue Pharma, LP on Oct 5, 2017 and is designated Class II. 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. The recall status is terminated (terminated Jan 24, 2020). Affected quantity: 3997 swabsticks.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 15, 2017
- Initiation Date
- Oct 5, 2017
- Termination Date
- Jan 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3997 swabsticks
Product description
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.
Distribution pattern
Nationwide in the USA
Code information
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0070-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026