Piramal Critical Care, Inc. recalls Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem
Recalled October 27, 2021 · FDA recall D-0019-2022 · Piramal Critical Care
Hazard
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT" · FDA Class II
Units
100 glass vials
Sold at
Nationwide within the United States
Description
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Product
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
Manufacturer(s)
Piramal Critical Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →