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.
Product description
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Lot numbers, UPCs & expiration codes
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0070-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 5, 2017
- FDA report date
- Nov 15, 2017
- Quantity
- 3997 swabsticks
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Purdue Pharma, LP
Original FDA data
Every field from FDA enforcement report D-0070-2018, exactly as published.
Show all FDA fields
- City
- Stamford
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 78229
- Address
- 1 Stamford Forum
- Code information
- Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
- Postal code
- 06901-3516
- Report date
- Nov 15, 2017
- Product type
- Drugs
- Recall number
- D-0070-2018
- Classification
- Class II
- Recalling firm
- Purdue Pharma, LP
- Product quantity
- 3997 swabsticks
- Termination date
- Jan 24, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 3, 2017