Recalls / Class II
Class IID-1102-2023
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.
- Affected lot / code info
- Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, N/A, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- 38,486 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-09
- FDA classified
- 2023-08-24
- Posted by FDA
- 2023-08-30
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1102-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.