Piramal Critical Care, Inc.: Drug Recall
Recall #D-0019-2022 · 09/10/2021
Class II: Risk
Recall Details
- Recall Number
- D-0019-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Piramal Critical Care, Inc.
- Status
- Terminated
- Date Initiated
- 09/10/2021
- Location
- Bethlehem, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 glass vials
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"
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
Distribution Pattern
Nationwide within the United States
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.