Camber Pharmaceuticals has recalled some of its pneumonia drugs because they may be contaminated with a bacteria that can permanently damage someone’s heart.
Atovaquone Oral Suspension – specifically lot #E220182 – contains a possible Bacillus cereus contamination, the US Food and Drug Administration said in a recall notice. People with compromised immune systems exposed to Bacillus cereus can develop bacterial infections or contract endocarditis — a potentially life-threatening heart valve inflammation, the FDA said.
Camber did not disclose how the bacteria could have gotten into its products. The New Jersey-based company said in a statement last month that no one has reported getting sick after using the recalled batch of atovaquone oral.
The recalled drug comes in a beige, 210 milliliter bottle with an expiration date of December 2023. Camber distributed the bottles to retail pharmacies, wholesalers and distributors nationwide, according to the recall notice. The FDA said any consumer or retailer should stop using or selling the product and throw it away.
Camber, a subsidiary of India-based Hetero Drugs, said it was notifying customers and distributors of the recall through postal mail and email. Customers with questions about recalls can call 1-877-597-0878 or email email@example.com. Anyone experiencing illness from the product can report the problem to the FDA online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088.
The atovaquone recall comes nearly four years after Camber recalled some blood pressure medications. The company recalled 87 lots of losartan in 2019 because the tablets contained an animal carcinogen — N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA. Hetero Labs found NMBA during testing of its products, the FDA said at the time.
Camber announced two recalls in 2018 — one in August for its heart failure drug valsartan and another in September for its asthma drug montelukast.
Christopher J. Brooks
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