FDA-Drug2021-10-27Class II
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Piramal Critical Care, Inc.
Hazard
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Sold states
Nationwide within the United States
Affected count
100 glass vials
Manufactured in
3950 Schelden Cir, N/A, Bethlehem, PA, United States
Products
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2022Don't want to check this manually?
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