FDA Drug recall D-0019-2022
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Ma…
- FDA Drug
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Ma… by Piramal Critical Care, citing labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT".
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0019-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-10 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Piramal Critical Care |
| Distribution | US |
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
Reason
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Identifiers
| code_info | Lot #: 20415001, 20415002, Expiration Date 05/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0019-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.