FDA-Drug2023-11-08Class II

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# 48433-230-15

Safecor Health, LLC
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
166,022 bottles
Manufactured in
317 New Boston St, N/A, Woburn, MA, United States
Products
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# 48433-230-15

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2024

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