Status
Terminated
Drug Enforcement D-0082-2024
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Classification
Class II
Report Date
November 8, 2023
Termination Date
November 8, 2024
Product Information
- 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
- Product quantity
- 166,022 bottles
- Reason for recall
- CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Distributed Nationwide in the USA
Location & Firm
- Recalling firm
- Safecor Health, LLC
- Address
-
317 New Boston St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0082-2024
- Event ID
- 93220
- Recall initiation date
- October 19, 2023
- Center classification date
- November 1, 2023
- 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
- More code info
- —