Drug product
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
D-1102-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 92857
- Status
- Completed
- Classification
- Class II
- Quantity
- 38,486 vials
- Official record key
drug-enforcement:D-1102-2023
Official wording
Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Code information: Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations