FDA recall D-0019-2022

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-09-10

Report date

2021-10-27

Termination date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2022