FDAFDA · Food and drugs·Recall number D-0019-2022
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
Published October 27, 2021 · Recall initiated: September 10, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Piramal Critical Care, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 20415001, 20415002, Expiration Date 05/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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