Home / Recalls / Piramal Critical Care, Inc. / D-0019-2022

D-0019-2022 Class II Terminated

Recalled by Piramal Critical Care, Inc. — Bethlehem, PA

Recall Details

Product Type: Drugs
Report Date: October 27, 2021
Initiation Date: September 10, 2021
Termination Date: September 7, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 100 glass vials

Product Description

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"

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 20415001, 20415002, Expiration Date 05/2022