Nephron recalls 5x4mL labetalol syringes due to lack of sterility assurance. This could lead to infections if used. Check NDC 69374-946-04 and lot numbers for affected products.
Lack of Assurance of Sterility
Nephron is recalling labetalol injections that may not be sterile, which could cause infections if used. This is serious because contaminated medication can lead to health risks.
The syringes lack proper sterility assurance, meaning they could contain harmful bacteria or other contaminants. If injected, this could cause infections or other health issues.
Patients prescribed labetalol injections by doctors who received these specific syringes. Those using the product without medical supervision are at risk.
Check for NDC 69374-946-04 on the packaging. Look for lot numbers LB1020A, LB1022A (expiring 5/21/2022), LB2003A (expiring 8/5/2022), or LB2007A (expiring 9/20/2022).
Immediately discard any recalled syringes to prevent potential infection.
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringes, NDC 69374-946-04.
Check the NDC code 69374-946-04 and lot numbers LB1020A, LB1022A (expiring 5/21/2022), LB2003A (expiring 8/5/2022), or LB2007A (expiring 9/20/2022).
Immediately discard the syringes to prevent potential infection.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-0961-2022 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-0961-2022 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.
