Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 1
Summary
The FDA issued a Class I for Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: K by KVK-Tech, Inc.. Reason: Temperature abuse: the firm received customer complaints of unusual grittiness in the product..
Details
Source
Drug Recall
External ID
D-0772-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
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.
Lot/Code Info: Batch # 16653A, 16654A, Exp 12/2022
Quantity Affected: 1,692 bottles
Reason for Recall
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Distribution
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-02
Company
Newtown, PA
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 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
KVK-Tech, Inc. has 4 FDA actions in our database, including 4 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 (KVK-Tech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does KVK-Tech, Inc. have FDA actions?
KVK-Tech, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0772-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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