Nephron recalls specific diltiazem injection bottles due to lack of sterility assurance. This affects certain 125mL single-dose containers with NDC 69374-997-15. Patients should contact their healthcare provider for safe alternatives.
Lack of Assurance of Sterility
Nephron is recalling diltiazem HCl injection bottles that may not be sterile. This could lead to infections if used improperly. Patients should not use these products and contact their doctor for alternatives.
The injection bottles lack proper sterility assurance, meaning they could contain harmful bacteria. If used without proper sterilization, this could cause serious infections in patients.
Patients prescribed this specific diltiazem injection by a healthcare provider. Those using the recalled product without medical supervision are at immediate risk of infection.
Look for bottles labeled 'Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container' with NDC 69374-997-15. The product was packaged in 15 bottles per carton and sold with a prescription.
Immediately stop using the recalled diltiazem injection bottles as they may not be sterile and could cause infections.
No, the recalled product lacks sterility assurance and could cause infections if used. Do not use this product.
Check for the NDC code 69374-997-15 on the bottle label. The product was packaged in 15 bottles per carton and sold with a prescription.
Contact your healthcare provider immediately for safe alternatives. Do not use the recalled product.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-0355-2023 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-0355-2023 from Nephron. 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.