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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Meitheal Pharmaceuticals Inc: Cisatracurium Besylate Injection Recalled for Label Mix-up

Agency Publication Date: February 22, 2021
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Summary

Meitheal Pharmaceuticals Inc. is recalling 34,860 vials of Cisatracurium Besylate Injection, USP (10 mg per 5 mL). This recall was initiated because some cartons were found to contain vials mislabeled as Phenylephrine Hydrochloride Injection, USP, even though the vials actually contain Cisatracurium. These products were distributed nationwide in the United States and were sold in cartons containing ten 5 mL single-dose vials.

Risk

Cisatracurium is a potent muscle relaxant used during surgery or with breathing machines; if it is mistaken for Phenylephrine (a blood pressure medication) and administered to a patient who is not sedated or being mechanically ventilated, it can cause respiratory failure, permanent airway damage, or death.

What You Should Do

  1. Check your medical supplies for Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL) Single-Dose Vials with NDC 71288-712-05 and carton NDC 71288-712-06.
  2. Specifically look for Lot Number C11507A on the vial or carton labels.
  3. Examine the individual vials inside the carton to ensure the label matches the carton; be aware that affected vials may incorrectly say 'Phenylephrine Hydrochloride Injection, USP'.
  4. Immediately stop using any products identified from Lot C11507A and quarantine them to prevent accidental administration.
  5. Contact your healthcare provider or pharmacist immediately for guidance if you have this medication, and return any unused product to the place of purchase for a refund.
  6. Contact Meitheal Pharmaceuticals Inc. directly at their Chicago headquarters for further instructions regarding the return and replacement process.
  7. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Return for refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL)
Model:
NDC 71288-712-05
NDC 71288-712-06
Lot Numbers:
C11507A

Product Images

Image of Incorrect Labeling

Image of Incorrect Labeling

Photo of the Mislabeled Product being recalled

Photo of the Mislabeled Product being recalled

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87224
Status: Resolved
Manufacturer: Meitheal Pharmaceuticals Inc
Sold By: hospitals; clinics
Manufactured In: United States
Units Affected: 34,860 vials
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 · FDA Press Release · 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.