Safecor Health, LLC: Drug Recall

Recall #D-0082-2024 · 10/19/2023

Class II: Risk

Recall Details

Recall Number
D-0082-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Safecor Health, LLC
Status
Terminated
Date Initiated
10/19/2023
Location
Woburn, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
166,022 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Distributed Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.