Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling | FDA

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Company Announcement

When a company announces a recall, withdraws from the market, or issues a security alert, the FDA publishes its announcement as a public service. The FDA neither recognizes products nor companies.

Meitheal Pharmaceuticals, Inc. ("Meithal") announced today that it has voluntarily recalled one (1) cistracurium besylate injection at USP 10 mg per 5 ml to user levels. The decision to recall the product was based on the product complaint showing that a part of the carton C11507A labeled as cistracurium besylate injection, each 5mL USP 10mg, each box contains 10 vials, of which 10 vials were mislabeled as hydrochloric acid Phenylephrine injection, USP 100mg/10ml. To date, Meitheal has not received any reports of adverse events or identifiable safety hazards in this batch.

There is a reasonable possibility that patients who need cis-atracurium to treat muscle paralysis during general anesthesia will not relax their skeletal muscles, and may cause increased blood pressure, arrhythmia and The high adrenaline state of cardiac/cerebral ischemia subsided. If not diagnosed and treated quickly, serious illness or death may result. 

There is a reasonable possibility that patients who need phenylephrine to raise blood pressure (such as patients with severely low blood pressure, especially patients who are treated with cissartracurium due to septic shock) may cause rapid onset of muscle paralysis and Reduce oxygen. If not diagnosed and treated quickly, serious illness or death may occur within a few minutes.

Cistracurium mesylate injection is used as a non-depolarizing neuromuscular blocker. The affected batch of kasatracurium besilate injection was C11507A, EXP. In October 2021, the product can be identified as a 5mL vial, plugged with a rubber stopper, and sealed with an aluminum seal with an Aqua color flip seal. Meitheal began shipping products to customers on August 19, 2020, and has already distributed them to wholesalers across the United States.

Meitheal has notified its distributors and customers in writing to arrange the return of all recalled products. Customers who bought the product should not open the carton or use the contents, but should immediately isolate and return many of the recalled products. Customers who may have distributed the product further should identify their customers immediately and notify them immediately when the product is recalled. 

Consumers who have questions about this recall can contact 844-824-8426 on working days in Central Standard Time (8:00 AM to 6:00 PM US Standard Time). If consumers encounter any problems related to taking or using this drug, they should contact their physician or healthcare provider.

Adverse reactions or quality problems encountered when using this product can be reported online, via regular mail or fax to the FDA's MedWatch Adverse Event Reporting Program, as described below.

Adverse reactions or quality problems encountered using this product can be reported to the FDA's MedWatch Adverse Event Reporting Program online via regular mail or fax.

The recall was carried out with the knowledge of the US Food and Drug Administration.

Since 2017, Meitheal Pharmaceuticals has bridged a major gap in the U.S. healthcare market by providing high-quality, affordable generic injections. Our wide range of products-from antibiotics, anticoagulants and muscle relaxants to drugs used in chemotherapy-provides practical solutions for countless patients across the country, as well as Meitheal's commitment to its care. Headquartered in Chicago, Illinois, our daily goal is to use our traditional Irish guiding principles called "Metheal (Mee·hall)" to produce quality and ensure affordable prices: working together for greater benefits , Work towards a common goal.

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