D-0082-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2023
- Initiation Date
- October 19, 2023
- Termination Date
- November 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 166,022 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
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