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On March 13, 2023, Camber Pharmaceuticals, Inc. issued a Voluntary Nationwide Recall on one lot of a pneumonia fighting drug after finding it might be contaminated with the Bacillus cereus bacteria. According to the National Institutes of Health, it is a “facultatively anaerobic, toxin-producing gram-positive bacterium found in soil, vegetation, and food.” When contacted, the bacteria can cause intestinal illnesses with nausea, vomiting, and diarrhea. However, it has been associated with severe infections in immunocompromised hosts and can cause blood poisoning as well as an infection of the tissues or fluids inside the eyeball, which can lead to vision loss.
The drug in question is the Atovaquone Oral Suspension, USP. This drug is indicated for the prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who are unable to tolerate other medicines, such as trimethoprim-sulfamethoxazole (an antibiotic that works by eliminating the bacteria that cause infections.) According to the risk statement released by Camber and the FDA, it states that the lot of Atovaquone Oral Suspension, USP, tests found that 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.
Those most at risk are those in the population who are immunocompromised; however, to date, Camber has not yet received any reports of adverse events related to this recall. Consumers who have taken the drug and are worried they have potentially contracted Bacillus cereus bacteria should be on the lookout for the following symptoms:
- Vomiting
- Nausea
- Diarrhea
Symptoms usually start anywhere from 8 to 16 hours after ingestion and can disappear in 12 to 24 hours. In some cases, the illness may be more severe. However, if you are showing signs of other, more serious symptoms, you should contact a medical professional immediately.
The recall covers the Atovaquone Oral Suspension drug in the 210mL high-density polyethylene (HDPE) bottle in a mono carton. Consumers can use other identifiers for the drug, including the following:
- NDC #: 31722-629-21
- UPC #: 331722629218
- LOT #: E220 182
- Exp. Date: 12/2023
Atovaquone Oral Suspension, USP, was distributed to wholesalers, distributors, retail pharmacies, and mail-order pharmacies like Amazon, GoodRX, CVS, Walmart, Costco, and Walgreens nationwide.
In the wake of the discovery, Camber Pharmaceuticals Inc. is notifying their distributors and consumers via their Reverse Logistics Company, Inmar, via mail and email. They are currently arranging for the returns of all recalled Atovaquone Oral Suspension, USP. The company is also asking its customers, distributors, and retailers that have the product to halt all use/sale of the drug immediately and to return or discard the product. If used, Camber urges consumers to contact a medical professional for help.
Per Camber, if you have or believe you have been affected by the recalled Atovaquone Oral Suspension, USP, and have questions regarding what you should do next, they ask that you reach out to Inmar, by emailing rxrecalls@inmar.com or calling their customer service line 877-597-0878. The FDA also requests that those customers who have had any medical problems from the drug to first seek help from a medical professional, then to contact them via its MedWatch Adverse Event page.
To learn more about the Camber Pharmaceuticals Inc. recall, or if you have been personally affected by Atovaquone Oral Suspension, USP, you can follow up with the story by connecting with one of our attorneys today. You can simply complete our free, no-obligation case evaluation form, and one of our team members will be in touch.