Piramal Critical Care, Inc. recalls Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehe…
- Recall date
- September 10, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0019-2022
- FDA classification
- Class II
- Brand / firm
- Piramal Critical Care, Inc.
- Sold / distributed
- Nationwide within the United States
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"
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Piramal Critical Care, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Piramal Critical Care, Inc.