Lugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations
Ecometics, Inc. is recalling Lugol's Strong Iodine Solution nationwide due to manufacturing quality deviations. Consumers with affected prescription vials should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving manufacturing practice violations (CGMP deviations). No illnesses, injuries, or deaths reported. Classified as High due to the manufacturing quality defect affecting a prescription pharmaceutical, though the specific nature of the defect and potential harm are not detailed in this notice.
Plain-English summary
Ecometics, Inc. is recalling Lugol's Strong Iodine Solution USP (8mL single-use vials, prescription-only) manufactured for CooperSurgical. The product contains 0.05 grams of iodine and 0.100 grams of potassium iodide per mL (NDC 59365-6064-0).
The recall was issued because the product was not manufactured under current good manufacturing practices (CGMP), meaning the manufacturing process did not meet FDA quality standards.
Approximately 38,486 vials were distributed nationwide in the USA. The affected lots are: Lot #2E235A (expiration 2/2024) and Lot #2E293A (expiration 3/2024).
Consumers who have this product should contact their healthcare provider or pharmacist for guidance. Do not use vials from the affected lots.
The recalled product
- 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.
- Manufacturer
- Ecometics, Inc.
- Hazard
- manufacturing-quality-defect
- cgmp-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 2E235A
- exp: 2/2024
- 2E293A
- exp: 3/2024
Distribution
Distributed nationwide across the United States.
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