Piramal Critical Care Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial recall — FDA D-0019-2022
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Overview of recall records associated with Piramal Critical Care, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
This page summarizes recall records in which the official source identifies Piramal Critical Care, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.