Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Reported: November 15, 2017 Initiated: October 5, 2017 #D-0070-2018
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.
Details
- Recalling Firm
- Purdue Pharma, LP
- Units Affected
- 3997 swabsticks
- Distribution
- Nationwide in the USA
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01. Recalled by Purdue Pharma, LP. Units affected: 3997 swabsticks.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 15, 2017. Severity: Moderate. Recall number: D-0070-2018.
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