Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1102-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Aug 9, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 38,486 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ecometics, Inc.
Original FDA data
Every field from FDA enforcement report D-1102-2023, exactly as published.
Show all FDA fields
- City
- Norwalk
- State
- CT
- Status
- Completed
- Country
- United States
- Event ID
- 92857
- Address
- 19 Concord St
- Code information
- Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024
- Postal code
- 06854-3706
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1102-2023
- Classification
- Class II
- Recalling firm
- Ecometics, Inc.
- Product quantity
- 38,486 vials
- Reason for recall
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2023