Recalls / Class II
Class IID-0082-2024
Product
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15
- Brand name
- Strong Iodine Solution
- Generic name
- Strong Iodine Solution
- Active ingredients
- Iodine, Potassium Iodide
- Route
- Oral
- NDC
- 48433-230
- Affected lot / code info
- Lot # 21A0073, Exp 11/30/2023; 21A0091, Exp. 12/31/2023; 21A0103, Exp 01/31/2024; 21A0135, Exp 03/31/2024; 22A0011, Exp 06/30/2024; 22A0019, Exp 07/31/2024; 22A0057, Exp 09/30/2024; 22A0083, Exp 11/30/2024; 22A0104, Exp 12/31/2024; 22A0110, Exp 01/31/2025; 22A0150, Exp 03/31/2025; 23A0007, Exp 06/30/2025; 23A0041, Exp 09/30/2025; 23A0045, Exp 11/30/2025; 23A0058, Exp 11/30/2025; 23A0067, Exp 11/30/2025; 23A0080, Exp 12/31/2025; 23A0090, Exp 01/31/2026
Why it was recalled
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 317 New Boston St, N/A, Woburn, Massachusetts 01801-6231
Distribution
- Quantity
- 166,022 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2023-10-19
- FDA classified
- 2023-11-01
- Posted by FDA
- 2023-11-08
- Terminated
- 2024-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0082-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.