Why it was recalled
Subpotent Drug
Product description
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03
Lot numbers, UPCs & expiration codes
Lot # 11901232, Exp. Date 09/30/2021 11901549, Exp. Date 11/30/2021 12000585, Exp. Date 03/31/2022 12000964, Exp. Date 5/31/2022 12001457, Exp. Date 7/31/2022 12002142, Exp. Date 12/31/2022 12100407, Exp. Date 03/31/2023 11901231, Exp. Date 09/30/2021 11901548, Exp. Date 11/30/2021 12000584, Exp. Date 03/31/2022 12000963, Exp. Date 05/31/2022 12001185, Exp. Date 06/30/2022 12001456, Exp. Date 07/31/2022 12002150, Exp. Date 12/31/2022 12100406, Exp. Date 03/31/2023
Where it was sold
Product was distributed nationwide.
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-0828-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 26, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 75,828 shippers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVRIO HEALTH L.P
Original FDA data
Every field from FDA enforcement report D-0828-2021, exactly as published.
Show all FDA fields
- City
- Stamford
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 88539
- Address
- 201 Tresser Blvd
- Code information
- Lot # 11901232, Exp. Date 09/30/2021 11901549, Exp. Date 11/30/2021 12000585, Exp. Date 03/31/2022 12000964, Exp. Date 5/31/2022 12001457, Exp. Date 7/31/2022 12002142, Exp. Date 12/31/2022 12100407, Exp. Date 03/31/2023 11901231, Exp. Date 09/30/2021 11901548, Exp. Date 11/30/2021 12000584, Exp. Date 03/31/2022 12000963, Exp. Date 05/31/2022 12001185, Exp. Date 06/30/2022 12001456, Exp. Date 07/31/2022 12002150, Exp. Date 12/31/2022 12100406, Exp. Date 03/31/2023
- Postal code
- 06901-3435
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0828-2021
- Classification
- Class II
- Recalling firm
- AVRIO HEALTH L.P
- Product quantity
- 75,828 shippers
- Termination date
- Apr 12, 2023
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Aug 26, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 23, 2021