Nationwide Recall of Prescription Strength Antifungal Drug - MedWaste Management Nationwide Recall of Prescription Strength Antifungal Drug - MedWaste Management

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FDA Recall Atovaquone Antifungal Drug

Nationwide Recall of Prescription Strength Antifungal Drug

In cooperation with the FDA, drug manufacturer AvKARE, LLC has announced a recall of Atovaquone Oral Suspension, USP 750 mg/5 mL. The prescription-strength antifungal drug is often used to treat PCP (Pneumocystis Pneumonia), a fungal infection of the lungs when the patient does not tolerate other first-line treatments. The drug may be contaminated with Bacillus cereus, which could lead to life-threatening infections.

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

NOTE: Approximately one year ago, we reported a similar recall of Atovaquone by a different manufacturer. You can find that recall here.

SUMMARY

Date of Recall:

Announced: April 1, 2024

Public Notification: April 1, 2024

Name(s) of Drug:

Atovaquone

Company Name:

AvKARE, LLC

Drug Indication:

PCP (Pneumocystis Pneumonia)

Fungal Infections

FDA Recall Atovaquone Antifungal Drug Packaging FDA Recall Atovaquone Antifungal Drug Package

Product Description

Atovaquone is available by prescription only and is distributed nationwide through wholesalers. The solution is contained within a bottle and packaged in a carton bearing the drug name and dosage and the NDC, Lot, and UPC numbers.

Reason for Recall

A third-party lab discovered the contamination of Bacillus cereus during routine testing. If a patient, particularly one who is immunocompromised should consume the tainted medication, they are at a high risk of life-threatening infections such as endocarditis (inflammation of the lining of the heart) or other necrotizing, soft tissue infections.

Impacts

Consumers who have received an affected batch of the medication and who consume the tainted drug may experience symptoms such as:

  • Vomiting
  • Diarrhea
  • Fever
  • Chills
  • Sweats
  • Weakness
  • Fatigue
  • Aches & Pains in Muscles/Joints
  • Shortness of Breath with Activity
  • Swelling of Feet, Legs, or Abdomen
  • Skin Infections that become increasingly painful or hot or begin to drain a grey liquid.

Recall Lot Information

Consumers should locate their medication packaging and compare NDC, lot, UPC numbers, and expiration dates with the chart below. If you find your NDC number, lot number, UPC number, and expiration date on the chart below, the recall will affect your medication. Read further for information on how to participate in recall procedures.

Product Description
NDC
UPC
Lot Number
Expiration Date

Atovaquone Oral Suspension, 750mg/5mL

50268-086-12 5026808612 AW0221A

08/2025

FDA.gov

 

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

Consumers

If you find that your lot of medication is part of this recall, do the following:

  1. Stop using the medication right away.
  2. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
  3. Monitor your health for any adverse symptoms and notify your physician if you have concerns.
  4. Consumers should contact AvKARE by telephone at 1-855-361-3993. They are available Monday through Friday from 9:00 a.m. to 5:00 p.m. (EST). You can also email them at drugsafety@avkare.com.
  5. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  6. 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 AvKARE at 1-855-361-3993 or utilize drugsafety@avkare.com to contact them via email. Notify them 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 AvKARE at 1-855-361-3993 or utilize drugsafety@avkare.com to contact them via email. Notify them 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 Healthcare Content Creator Byline Image

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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