- Company Announcement Date:
- March 13, 2023
- FDA Publish Date:
- March 31, 2023
- Product Type:
- Reason for Announcement:
Recall Reason Description
Potential Bacillus cereus Contamination
- Company Name:
- Camber Pharmaceuticals, Inc.
- Brand Name:
- Product Description:
Device & Drug Safety/Microbial Contamination/Bacillus cereus
FOR IMMEDIATE RELEASE – 3/13/2023 – Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.
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, Camber 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 Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.
The product is packaged in 210mL HDPE bottle in a mono carton. The identified NDC # associated with the product is 31722-629-21, UPC # 331722629218, and the affected lot# is E220182 with an expiration date of 12/2023.
Camber Pharmaceuticals, Inc. is notifying its distributors and customers by our Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.
Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.
Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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