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
Reported: October 27, 2021 Initiated: September 10, 2021 #D-0019-2022
Product Description
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"
Details
- Recalling Firm
- Piramal Critical Care, Inc.
- Units Affected
- 100 glass vials
- Distribution
- Nationwide within the United States
- Location
- Bethlehem, PA
Frequently Asked Questions
What product 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. Recalled by Piramal Critical Care, Inc.. Units affected: 100 glass vials.
Why was this product recalled? ▼
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 27, 2021. Severity: Moderate. Recall number: D-0019-2022.
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