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 mL5mL Multi-Dose VialRx 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 #: 2041500120415002Expiration 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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