Recalls / Class II
Class IID-0019-2022
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
- Affected lot / code info
- Lot #: 20415001, 20415002, Expiration Date 05/2022
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"
Recalling firm
- Firm
- Piramal Critical Care, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3950 Schelden Cir, N/A, Bethlehem, Pennsylvania 18017-8936
Distribution
- Quantity
- 100 glass vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-09-10
- FDA classified
- 2021-10-20
- Posted by FDA
- 2021-10-27
- Terminated
- 2022-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0019-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.