July 2021 FDA Recall Atovaquone Oral Suspension by Kvk-tech, Inc.
D-0772-2021 - Temperature abuse
This Class I drug recall was voluntarily initiated by Kvk-tech, Inc. on July 2, 2021 for the product Atovaquone Oral Suspension. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0772-2021
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
07-02-2021
09-01-2021
1,692 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
KVK-Tech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
05-23-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
