Piramal Recalls Rocuronium Bromide Vials Due to Labeling Errors
Piramal Critical Care recalls specific lots of Rocuronium Bromide Injection vials because the label lacks the required 'WARNING: PARALYZING AGENT' statement.
Use caution until it’s fixed
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Contact the company
What happened, in plain English
Piramal Critical Care, Inc. is recalling a small quantity of Rocuronium Bromide Injection 50mg/5 mL multi-dose vials. The issue is that the flip cap vial labels are missing the mandatory warning statement: "WARNING: PARALYZING AGENT". This omission could lead to improper handling or administration of the drug. Read more at govinfonow.com/recall/35857-piramal-recalls-rocuronium-bromide-vials-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/35857-piramal-recalls-rocuronium-bromide-vials-due-to-labeling-errors · Updated October 10, 2026 · FDA enforcement record: FDA #D-0019-2022
Cite this page
“Piramal Recalls Rocuronium Bromide Vials Due to Labeling Errors.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35857-piramal-recalls-rocuronium-bromide-vials-due-to-labeling-errors. Based on FDA recall #D-0019-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0019-2022%22&limit=1).
Why it’s dangerous
Rocuronium Bromide is a paralyzing agent used in medical settings. The absence of the required "WARNING: PARALYZING AGENT" label means healthcare workers might not immediately recognize the extreme potency and risks associated with the drug, potentially leading to accidental exposure or misuse.
Who’s affected
Healthcare providers and facilities in the United States that received the affected lots of this prescription drug are likely to be affected. Patients who received treatment with these specific vials may also be at risk if the missing warning led to improper use.
How to tell if you have this one
Check for Rocuronium Bromide Injection 50mg/5 mL in 5mL Multi-Dose Vials manufactured by Sanovel Ilac. Look for NDC 66794-0228-41 and Lot numbers 20415001 or 20415002 with an expiration date of 05/2022.
- Brand
Piramal Critical Care- Category
Drug
What to do — step by step
Identify Affected Vials
Check your inventory for Rocuronium Bromide Injection vials with NDC 66794-0228-41 and Lot numbers 20415001 or 20415002.
Contact Manufacturer
Since the remedy is not stated in the record, contact Piramal Critical Care directly for instructions on how to return or dispose of the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0019-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0019-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.