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
Reported: November 8, 2023 Initiated: October 19, 2023 #D-0082-2024
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
Reason for Recall
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Details
- Recalling Firm
- Safecor Health, LLC
- Units Affected
- 166,022 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Woburn, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Safecor Health, LLC. Units affected: 166,022 bottles.
Why was this product recalled? ▼
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2023. Severity: Moderate. Recall number: D-0082-2024.
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