FDA recall D-0082-2024

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# 48433-230-15

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-10-19

Report date

2023-11-08

Termination date

2024-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woburn, MA, United States

Primary source

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