Elevated risk U.S. Food and Drug Administration

AVpak Atovaquone Oral Suspension, USP 750mg/5mL recall: Potential Bacillus cereus contamination

Recall published 2+ years ago

Potential Bacillus cereus contamination

AVpak Prescription & OTC drugs — recalled prescription & otc drugsAVpak Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

What the notice says: Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 1, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
AVpak
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Atovaquone Oral Suspension, USP 750mg/5mL

What the company announced

FOR IMMEDIATE RELEASE – 3/29/2024 –AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, AvKARE has not received any reports of adverse events related to this recall.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 Nationwide to Wholesalers.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.

Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC.

Consumers that have product which is being recalled should stop using the product and return it to place of purchase or discard. Consumers with questions regarding this recall can contact AvKARE by phone at 1-855-361-3993 or email [email protected] , Monday – Friday, 9am – 5pm Eastern Time. 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.

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-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AW0221A
  • USP 750mg/5mL

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08/2025

Package size

Match the net weight or the piece count on the front of the pack.

  • 750 mg
  • 5 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

AVpak — A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Consumers that have product which is being recalled should stop using the product and return it to place of purchase or discard.

Company contact: AvKARE, LLC — Consumers: AvKARE, 1-855-361-3993, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was AVpak prescription & otc drugs recalled?

Potential Bacillus cereus contamination Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AW0221A, USP 750mg/5mL; best-by date 08/2025. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: Consumers that have product which is being recalled should stop using the product and return it to place of purchase or discard.

Where was the recalled product sold?

It was distributed nationwide.

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