Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Rocuronium Bromide Injection 50mg/5 mL Recalled by Piramal Critical Care, Inc. Due to Labeling: Label Lacks Warning or Rx Legend: Finished...

Date: September 10, 2021
Company: Piramal Critical Care, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Piramal Critical Care, Inc. directly.

Affected Products

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

Quantity: 100 glass vials

Why Was This Recalled?

Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Piramal Critical Care, Inc.

Piramal Critical Care, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report