Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem
Summary
The FDA issued a Class II for Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactur by Piramal Critical Care, Inc.. Reason: Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT".
Details
Source
Drug Recall
External ID
D-0019-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 20415001, 20415002, Expiration Date 05/2022
Quantity Affected: 100 glass vials
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
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-10
Company
Bethlehem, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Piramal Critical Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Piramal Critical Care, Inc. have FDA actions?
This is the only FDA action we have on record for Piramal Critical Care, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0019-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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