Sun Pharmaceutical recalls norepinephrine injection vials with impurity levels above safety limits. This may cause adverse reactions. Stop using and contact for details.
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Sun Pharmaceutical is recalling norepinephrine injection vials that contain impurities above safe levels. Using these vials could lead to adverse reactions in patients.
The injection vials contain higher levels of norepinephrine sulfonic acid impurities than allowed. This could cause adverse reactions in patients receiving the medication.
Patients prescribed norepinephrine injections by healthcare providers. Those using the recalled vials are at risk of adverse reactions.
Check for vials labeled 'Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40)'. The vials were manufactured with lot numbers G1510001, G1510002, or G1510003 and expire by November 2023, December 2023, or February 2024.
Look for the product name and NDC code 47335-615-40 on the vial label.
Inform your healthcare provider about the recalled vial if you have been prescribed this medication.
No, the recalled vials contain impurities above safe levels and may cause adverse reactions.
Contact your healthcare provider to discuss next steps. Do not use the vial.
Check for the NDC code 47335-615-40 and lot numbers G1510001, G1510002, or G1510003.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0529-2023 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0529-2023 from Sun Pharmaceutical. 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.
