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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nephron Rocuronium Bromide Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: January 9, 2023
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Summary

Nephron Sterile Compounding Center LLC is recalling 38,830 syringes of Rocuronium Bromide Injection (50 mg/5 mL). Rocuronium bromide is a medication used by healthcare providers during surgery or other medical procedures to relax muscles. The recall was initiated because there is a lack of assurance that the medication is sterile. No injuries or illnesses related to this recall have been reported to date.

Risk

If an injectable medication is not sterile, it can introduce bacteria or other contaminants directly into the patient's body, which may lead to life-threatening infections or other severe medical complications.

What You Should Do

  1. The recalled product is Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), sold in cartons of six 5-syringe packs with NDC 69374-924-05.
  2. Check your inventory for lot number RC2011A with an expiration date of 2/22/2023.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Rocuronium Bromide Injection (50 mg/5 mL)by Nephron 503B outsourcing facility
Variants: 10 mg/mL, 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton
Lot Numbers:
RC2011A (Exp. 2/22/2023)
NDC:
69374-924-05

Recalled due to lack of assurance of sterility.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91450
Status: Resolved
Manufacturer: Nephron Sterile Compounding Center LLC
Sold By: Nephron 503B outsourcing facility
Manufactured In: United States
Units Affected: 38,830 syringes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.