Rocuronium Bromide Injection 50mg/5 mL — Class II drug recall D-0019-2022
Terminated recall by Piramal Critical Care, Inc., reported 2021-10-27, distributed nationwide. Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap via
| Recall number | D-0019-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Piramal Critical Care, Inc., Bethlehem, PA, United States |
| Recall initiated | 2021-09-10 |
| Classified | 2021-10-20 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2022-09-07 |
| Distributed | Nationwide (US) |
| Quantity | 100 glass |
| Reason classes | labeling |
| NDC | 66794-0228-41 |
| Lot numbers | 20415001, 20415002 |
| Expiration dates | 2022-05 |
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 for recall
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0019-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.