Atovaquone Oral Suspension
FDA Recall NDC 10702-223
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atovaquone Oral Suspension (NDC 10702-223). A significant event, classified as Class I, was initiated on Jul 02, 2021 by Kvk-tech, Inc.. The reported reason for this action was: "Temperature abuse: the firm received customer complaints of unusual grittiness in the product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Jul 02, 2021
Sep 01, 2021
1,692 bottles
Recall Profile & Regulatory Data
Event ID
88220
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Termination Date
May 23, 2022
Product Description
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
Batch or Lot Expiration Information
Batch# 16653A, 16654A, Exp 12/2022
Affected Packages Involved in this Recall
10702-223-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
