Piramal Critical Care recalls 50mg/5mL Rocuronium Bromide Injection vials that lack a critical warning label about paralyzing effects. This may lead to unintended paralysis during medical procedures.
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Piramal Critical Care is recalling 50mg/5mL Rocuronium Bromide Injection vials that do not have the required warning label about paralyzing effects. This could cause unintended paralysis during medical procedures if used without the warning.
The vial lacks the required warning label stating 'WARNING: PARALYZING AGENT'. This means healthcare providers might not realize the drug's paralyzing effect during medical procedures, potentially causing unintended muscle paralysis.
Healthcare professionals who use this medication for anesthesia or surgery. Patients receiving this drug under medical supervision are at risk if the warning label is missing.
Check for vials labeled 'Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only' with NDC 66794-0228-41 and lots 20415001 or 20415002 manufactured before May 2022.
Look for the missing 'WARNING: PARALYZING AGENT' label on the flip cap vial.
The vial lacks the required warning label stating 'WARNING: PARALYZING AGENT', which could lead to unintended paralysis during medical procedures.
Check for the missing warning label. If you find it, contact your healthcare provider for guidance on safe use.
The recall record does not specify a remedy, so contact your healthcare provider for advice.
We’ve drafted a message you can send Piramal Critical Care to request your refund or repair — edit it as you like.
Subject: Recall D-0019-2022 — Piramal Critical Care Piramal Critical Care Hello, I own a Piramal Critical Care that is covered by recall D-0019-2022 from Piramal Critical Care. 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.
