FDAClass IINovember 8, 2023

Strong Iodine Solution U.S.P recall: CGMP Deviations

Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC#…

Why was Strong Iodine Solution U.S.P recalled?

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 21A0073, Exp 11/30/2023; 21A0091, Exp. 12/31/2023; 21A0103, Exp 01/31/2024; 21A0135, Exp 03/31/2024; 22A0011, Exp 06/30/2024; 22A0019, Exp 07/31/2024; 22A0057, Exp 09/30/2024; 22A0083, Exp 11/30/2024; 22A0104, Exp 12/31/2024; 22A0110, Exp 01/31/2025; 22A0150, Exp 03/31/2025; 23A0007, Exp 06/30/2025; 23A0041, Exp 09/30/2025; 23A0045, Exp 11/30/2025; 23A0058, Exp 11/30/2025; 23A0067, Exp 11/30/2025; 23A0080, Exp 12/31/2025; 23A0090, Exp 01/31/2026

Product
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC#…
Recalling firm
Safecor Health, LLC
Quantity
166,022 bottles
Distribution
Distributed Nationwide in the USA
Recall date
November 8, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls