Safecor Health recalls iodine solution bottles due to missing USP manufacturing standards. This medication is prescription-only and may not be safe for use.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Safecor Health is recalling prescription iodine solution bottles because they were made without proper USP manufacturing standards. This could mean the product isn't safe for medical use.
The product was made without following USP manufacturing standards, which could affect its safety and effectiveness. This is a quality control issue that may not cause immediate harm but could lead to improper treatment.
Prescription patients who received this iodine solution from Safecor Health. Those with medical conditions requiring iodine treatment are most at risk.
Look for Safecor Health's Strong Iodine Solution (Lugol's Solution) 14 mL glass dropper bottles in boxes. The product has NDC# 48433-230-15 and specific lot numbers with expiration dates listed in the recall.
Verify the NDC number and lot numbers listed in the recall to confirm if your product is affected.
The recall states the product was made without USP manufacturing standards, but it does not say it is unsafe for use. Patients should consult their doctor.
The recall does not specify a remedy, so you should check with your doctor or pharmacist for guidance.
Check the NDC number (48433-230-15) and lot numbers listed in the recall to see if your product matches.
We’ve drafted a message you can send Safecor to request your refund or repair — edit it as you like.
Subject: Recall D-0082-2024 — Safecor Safecor Hello, I own a Safecor that is covered by recall D-0082-2024 from Safecor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.