Atovaquone FDA Alerts
The FDA Alerts below may be specifically about atovaquone or relate to a group or class of drugs which include atovaquone.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for atovaquone
AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination
March 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 drugsafety@avkare.com, 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.
Source: FDA
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product
March 31, 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 rxrecalls@inmar.com, 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.
Source: FDA
KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature Abuse
August 6, 2021 -- KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.
Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. Severely immunocompromised patients who receive less effective Atovaquone Oral Suspension may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.
Atovaquone is a prescription drug labeled to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults and is also used to prevent immunocompromised patients from contracting this type of pneumonia.
The product is packaged in 8 oz bottles (Bottle of 210 mL with child-resistant cap) packaged in a carton, NDC# 10702-223-21, the affected lots are labeled 16653A and 16654A, with both lots having expiration dates of December 2022. The lot numbers and expiration dates can be found on the Right Bottom Side of the labels on the bottles.
The two lots of product were shipped to a single distributor, which has been notified as part of the recall. KVK Tech will be working with the distributor to ensure that the distributor’s customers return remaining inventory of the affected lots to KVK Tech for appropriate disposition. Patients or caregivers who have bottles of Atovaquone affected by this recall should stop using and are requested to return the product to KVK Tech at 110 Terry Drive, Newtown, PA 18940, and KVK Tech will arrange to reimburse customers for their costs in purchasing the product.
Consumers with questions regarding this recall can contact KVK Tech at 215-579-1842 Ext: 6002 Monday – Friday, 8:00 am – 4:30 pm EST or recall@kvktech.com. 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
- Regular Mail or Fax: Download form 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.
Source: FDA
