Reported Oct 27, 2021 · Terminated

Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care,…

Piramal Critical Care, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Piramal Critical Care, Inc. · 3950 Schelden Cir · Bethlehem, PA · 18017-8936

Is this the product you have?

    • Rocuronium Bromide Injection 50mg/5 mL
    • 5mL Multi-Dose Vial
    • Rx only
  • Manufactured forPiramal Critical Care, Bethlehem, PA 18017, USA
  • Manufactured bySanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Lot codes and dates
    • Lot #: 20415001
    • 20415002
    • Expiration Date 05/2022
Amount recalled
100 glass vials

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 7, 2022 · Data as of Sep 19, 8:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.