Nephron recalls 30-unit vial of PF-Labetalol HCl Injection due to potential cross-contamination during manufacturing. This medication is for prescription use only.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Nephron is recalling 30 vials of PF-Labetalol HCl injection that may have cross-contaminated during manufacturing. This could affect patients using the medication for blood pressure treatment.
The medication may have cross-contaminated during manufacturing, meaning other drugs could be present in the vial. This could cause harmful reactions when injected.
Patients prescribed PF-Labetalol HCl injection by a doctor are affected. Those using the medication for blood pressure treatment are most at risk.
Check for vials labeled PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), packaged in 30 vials per carton. The NDC code is 69374-946-34 and lot number LB2005A.
Look for the product name, NDC code, and lot number on the vial packaging.
The recall states there is a potential for cross-contamination, but no specific safety issues have been reported.
Check for vials labeled PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), packaged in 30 vials per carton with NDC 69374-946-34 and lot number LB2005A.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-1347-2022 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-1347-2022 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.
