Rocuronium Bromide Injection 50mg/5 mL recall: Labeling Error
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured…
Why was Rocuronium Bromide Injection 50mg/5 mL recalled?
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 20415001, 20415002, Expiration Date 05/2022
- Product
- Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured…
- Recalling firm
- Piramal Critical Care, Inc.
- Quantity
- 100 glass vials
- Distribution
- Nationwide within the United States
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)