FDA MedWatch - Cisatracurium Besylate Injection - USP, 10 mg per 5 mL by Meitheal Pharmaceuticals: Recall - Due to Mislabeling

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Cisatracurium Besylate Injection - USP, 10 mg per 5 mL by Meitheal Pharmaceuticals: Recall - Due to Mislabeling  AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Meitheal Pharmaceuticals is recalling one (1) lot of Cisatracurium Besylate Injection - USP, 10 mg per 5 mL because the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection - USP, 10 mg per 5 mL, containing 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP - 100 mg per 10 mL. To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot. There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle relaxation and could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia and cardiac/brain ischemia. If this is not quickly diagnosed and treated, severe illness or death can occur. There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure, especially resulting from septic shock who is administered cisatracurium instead could result in a fast onset of muscle paralysis and decrease in oxygen. If this is not quickly diagnosed and treated, severe illness or death can occur within minutes. For more information about this recall click on red button "Read Recall" below. BACKGROUND: Cisatracurium Besylate Injection is used as a nondepolarizing neuromuscular blocker.  RECOMMENDATIONS:  Customers who have purchased the product should not open the carton or use its contents and should immediately quarantine and return the recalled lot of product. Customers who may have further distributed this product should promptly identify their customers and notify them at once of this product recall. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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