Betaxolol Hydrochloride Tablet, Coated
FDA Recall NDC 10702-014
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 Betaxolol Hydrochloride (NDC 10702-014). A significant event, classified as Class I, was initiated on Sep 20, 2023 by Kvk-tech, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles."
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
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Sep 20, 2023
Oct 25, 2023
1488 bottles
Recall Profile & Regulatory Data
Event ID
93101
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
Termination Date
Jul 29, 2025
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.
Batch or Lot Expiration Information
Lot# 17853A, Exp. 06/30/2027
Affected Packages Involved in this Recall
10702-013-01Product
10702-014-01Product
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.
