Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pul
Summary
The FDA issued a Class I for Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons by AvKARE. Reason: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination..
Details
Source
Drug Recall
External ID
D-0444-2024
Action Date
2024-04-24
Status
Terminated
Category
drug
Product Description
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
Lot/Code Info: Lot: AW0221A Exp. 08/30/2025
Quantity Affected: 153 cartons
Reason for Recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-28
Company
Pulaski, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 26 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AvKARE has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AvKARE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AvKARE have FDA actions?
AvKARE has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0444-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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