Recalls / Class II
Class IID-0828-2021
Product
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
- Brand name
- Betadine
- Generic name
- Povidone-iodine
- Active ingredient
- Povidone-iodine
- Route
- Topical
- NDC
- 67618-153
- FDA application
- M003
- Affected lot / code info
- 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
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- AVRIO HEALTH L.P
- Manufacturer
- Atlantis Consumer Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Tresser Blvd, Stamford, Connecticut 06901-3435
Distribution
- Quantity
- 75,828 shippers
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-08-26
- FDA classified
- 2021-09-23
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-04-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0828-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.