ATOVAQUONE
Generic: ATOVAQUONE, ATOVAQUONE ORAL SUSPENSION
PAI HoldingsManufacturer
ORALRoute
ATOVAQUONEActive Substance
2021-10-25Original Approval
ATOVAQUONE is FDA application ANDA214272, sponsored by PAI HOLDINGS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class I2024-09-17
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 0854Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohn
Class I2021-07-02
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 1Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class I2023-03-13
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereu
Top Reported Reactions
1
OFF LABEL USE
738 reports
2
DRUG INEFFECTIVE
383 reports
3
PYREXIA
360 reports
4
DIARRHOEA
348 reports
5
PNEUMONIA
336 reports
6
NAUSEA
328 reports
7
CONDITION AGGRAVATED
252 reports
8
ACUTE KIDNEY INJURY
246 reports
9
DEATH
241 reports
10
THROMBOCYTOPENIA
238 reports