Recalls / Class II
Class IID-0070-2018
Product
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
- Brand name
- Betadine
- Generic name
- Povidone-iodine
- Active ingredient
- Povidone-iodine
- Route
- Topical
- NDC
- 67618-153
- FDA application
- M003
- Affected lot / code info
- Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
Why it was 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.
Recalling firm
- Firm
- Purdue Pharma, LP
- Manufacturer
- Atlantis Consumer Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Stamford Forum, N/A, Stamford, Connecticut 06901-3516
Distribution
- Quantity
- 3997 swabsticks
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-05
- FDA classified
- 2017-11-03
- Posted by FDA
- 2017-11-15
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0070-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.