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.
Reported: August 30, 2023 Initiated: August 9, 2023 #D-1102-2023
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.
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Details
- Recalling Firm
- Ecometics, Inc.
- Units Affected
- 38,486 vials
- Distribution
- Nationwide in the USA
- Location
- Norwalk, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ecometics, Inc.. Units affected: 38,486 vials.
Why was this product recalled? ▼
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1102-2023.
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