Nephron recalls Ketorolac injection vials due to potential cross-contamination from manufacturing deviations. Affected lots expire 8/31/2022. No action needed if not in the specific lot.
cGMP Deviations: deviations leading to potential cross-contamination.
Nephron is recalling Ketorolac injection vials that may have cross-contaminated during manufacturing. This could affect patients receiving the medication, though no injuries have been reported.
The medication was produced under manufacturing deviations that could lead to cross-contamination. This means other substances might be present in the injection, potentially causing harm if used.
Patients prescribed Ketorolac injection by a doctor. Those using the specific lot number (023011) from the recalled batch are most at risk.
Check for the lot number 023011 on the vial label. The product is a 2 mL single-dose vial of Ketorolac injection, sold by Nephron Pharmaceutical Corporation.
Look for the lot number 023011 on the vial label. If present, the vial is part of the recall.
The recall is due to potential cross-contamination from manufacturing deviations. If you have the specific lot number 023011, you should check with your doctor before using.
Check the vial label for lot number 023011. If it matches, contact your doctor to discuss whether to stop using it.
The recall is for potential cross-contamination, which could cause harm. However, no injuries have been reported, and the risk is considered low.
We’ve drafted a message you can send Nephron to request your refund or repair — edit it as you like.
Subject: Recall D-1354-2022 — Nephron Nephron Hello, I own a Nephron that is covered by recall D-1354-2022 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.
