Drug 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
D-0019-2022
Product summary
- Event
- Event 88841
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 glass vials
- Official record key
drug-enforcement:D-0019-2022
Official wording
Reason: Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Code information: Lot #: 20415001, 20415002, Expiration Date 05/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Label Lacks Warning or Rx Legend: Finished product did not include