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                Recalls, Market Withdrawals, & Safety Alerts

Recalls, Market Withdrawals, & Safety Alerts

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          Recalls, Market Withdrawals, & Safety Alerts
          Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During ManufacturingRecalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT
    
  
  
  Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing

  
    
        When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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  Company Announcement Date:
             January 24, 2024

                          FDA Publish Date: 
               January 25, 2024
                                    Product Type: 
              Drugs
                          Reason for Announcement:
              Recall Reason Description
              Mislabeled package

            Company Name: 
              Azurity Pharmaceuticals, Inc.

            Brand Name:
              Brand Name(s)
          Zendedi

            Product Description:
              Product Description
          dextroamphetamine sulfate tablets, 30 mg   
Company Announcement



**FOR IMMEDIATE RELEASE –** January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).

To date, Azurity has not received any reports of serious adverse events related to this recall.

Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc. For additional Zenzedi® safety information, please visit www.azurity.com.

Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Product was distributed nationwide through pharmacies.

Product
			NDC No.
			Lot No.
			Exp. Date
			Ship Dates to
			WholesalersZenzedi®
			(dextroamphetamine
			sulfate tablets, USP)
			30 mg
			24338-856-03
			F230169A
			2025-06
			08/23/2023 –
			11/29/2023

Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers that have product which is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product. Azurity has enlisted the services of Inmar Intelligence to facilitate the recall. Inmar is located at 3845 Grand Lakes Way, Grand Prairie, TX 75050. All returns from wholesalers and retailers must go to Inmar at this address.

For more information regarding this recall, please reference the following telephone numbers:

For information regarding the recall process, call Inmar Intelligence at **877-804-2069** (Monday through Friday, 9AM-5PM EST).
	For medical or technical product information or to report a technical product complaint or adverse event please call **800-461-7449** (Monday through Friday, 9AM-5PM EST).Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. An adverse event may also be reported to Azurity via email at aereports@azurity.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report **Online:** www.fda.gov/medwatch/report.htm
	**Regular Mail or Fax:** Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.





Company Contact Information
  
  
    Consumers:       

                 Azurity
        
        
                 aereports@azurity.com
    Media:
      
              Liz Flynn
      
              781-281-3225



  Product Photos

            Image of bottle with label, Zenzedi Rx only 30 mg
    Image of tablets of Zenzedi 30 mg, light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side

                                                                                  Content current as of:
      01/25/2024
               
             
Regulated Product(s)
		 Drugs   
        
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