Recall: Children's ADHD/Adult Narcolepsy Medication Mix-up - MedWaste Management Recall: Children's ADHD/Adult Narcolepsy Medication Mix-up - MedWaste Management

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Zenzedi FDA Recall 2024

Recall: Children’s ADHD/Adult Narcolepsy Medication Mix-up

The FDA has issued a very concerning and immediate recall of a medication used to treat ADHD (attention-deficit/hyperactivity disorder) in children and Narcolepsy in adults. Zendedi, also labeled as dextroamphetamine sulfate, was mixed up with Carbinoxamine Maleate, an antihistamine. This means that patients who believe they are taking Zendedi may be taking doses of an antihistamine. Conversely, patients who are prescribed the antihistamine may be taking doses of the stimulant medication. There have been no reports indicating that any Zenzedi tablets are included in the bottles labeled “Carbinoxamine Maleate.” Regardless, each patient who takes the medication is at risk.

As of the writing of this notice, the FDA has not reported any adverse events related to this recall.

SUMMARY

Date of Recall:

Announced: January 24, 2024

Public Notification: January 25, 2024

 

Name(s) of Drugs:

Zendedi (dextroamphetamine sulfate), 30 mg

 

Company Name:

Azurity Pharmaceuticals, Inc.

 

Drug Indication:

Pediatric ADHD

Narcolepsy

Zenzedi bottle Zenzedi tablet

Product Description

The medications are available by prescription only and are distributed by pharmacies nationwide. Zenzedi (dextroamphetamine sulfate), 30 mg tablets are packaged in a white bottle. Each tablet is embossed with “MIA” on one side and “30” on the other.

Carbinoxamine Maleate, the antihistamine involved in the mix-up, is a white tablet embossed with “GL” on one side and “211” on the other.

Reason for Recall

A pharmacist discovered that a bottle labeled as Zenzedi (dextroamphetamine sulfate), 30 mg in his stock was filled with Carbinoxamine Maleate tablets. He notified the manufacturer, prompting the issuance of the recall.

Impacts

The high risk for impact makes this mix-up extremely dangerous for consumers involved.

Patients who suddenly stop receiving their ADHD or Narcolepsy medication (due to unknowingly ingesting an antihistamine instead) may experience a resurgence of their symptoms. Additionally, sudden discontinuation of the medication can cause severe tiredness and depression. Side effects of the antihistamine medication also include drowsiness, leading to serious functional impairment and a high risk of accidents or injury. The probability exists that the sedating effects of taking this incorrect medication could lead to disability or death.

Additional side effects associated with taking Carbinoxamine Maleate include:

  • Central Nervous System (CNS) depression
  • Increased Eye Pressure
  • Enlarged Prostate Urinary Obstruction
  • Thyroid Disorders

Lot Information

At this time, the recall includes a single lot of medication. Consumers who take (or whose children take) Zenzedi are strongly encouraged to compare the information on their medication bottle to the chart below. If the medication matches, see below for further instructions.

Product Description

NDC Number

Lot Number Expiration Date

Dates Shipped to Wholesalers

Zenzedi® (dextroamphetamine sulfate tablets, USP 30 mg) 24338-856-03 F230169A 06-2025 08/23/2023-11/29/2023

FDA.gov

Have you found that your (or your child’s) medication is part of the recall? Here’s what you should do:

Consumers

  1. Stop using the medication immediately.
  2. Immediately notify your doctor/Pediatrician if you or your child has used the recalled medication.
  3. Contact your pharmacy and request a replacement bottle of medication.
  4. Follow your physician/Pediatrician’s instructions for restarting the medication.
  5. Closely monitor your health (the health of your child if they are the consumer) for adverse symptoms and notify your doctor/Pediatrician of any changes.
  6. Consumers may contact Inmar Intelligence at 1-877-804-2069. They are available Monday through Friday from 9:00 a.m. to 5:00 p.m. (EST). You can also email them at aereports@azurity.com.
  7. If you are currently experiencing or have experienced an adverse reaction to the medication, notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  8. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Inmar Intelligence at 1-877-804-2069, or you can utilize aereports@azurity.com to contact them via email. Notify Inmar of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Inmar Intelligence at 1-877-804-2069, or you can utilize aereports@azurity.com to contact them via email. Notify Inmar of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse Writer

 

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

 

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