SCA Pharmaceuticals recalls 125mg Diltiazem HCl injection due to lack of sterility assurance. This prescription-only product (NDC 70004-0541-35) may pose infection risks if used.
Lack of Assurance of Sterility
SCA Pharmaceuticals is recalling a specific prescription injection product because it lacks proper sterility assurance. This could lead to infections if the medication is used without being properly sterilized.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. If used without proper sterilization, this could cause infections in patients receiving the injection.
Prescription patients who received this specific Diltiazem HCl injection product. Healthcare providers using the product for medical treatment are at risk.
Check for the product name 'Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag'. Look for NDC 70004-0541-35, Lot #1223049625, and expiration date 1/24/24.
Verify the product name, NDC number, lot number, and expiration date to confirm if it's recalled.
The recall indicates a lack of sterility assurance, so it should not be used. The product may pose infection risks.
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe alternatives.
Check the product label for NDC 70004-0541-35, Lot #1223049625, and expiration date 1/24/24.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0394-2024 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0394-2024 from SCA Pharmaceuticals. 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.
