Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10
Summary
The FDA issued a Class I for Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., by KVK-Tech, Inc.. Reason: Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles..
Details
Source
Drug Recall
External ID
D-0049-2024
Action Date
2023-10-25
Status
Terminated
Category
drug
Product Description
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Lot/Code Info: Lot # 17853A, Exp. 06/30/2027
Quantity Affected: 1488 bottles
Reason for Recall
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Distribution
Nationwide in the USA and PR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-20
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 48 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-0049-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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