September 2023 FDA Recall Betaxolol Hydrochloride by Kvk-tech, Inc.
D-0049-2024 - Presence of Foreign Tablets/Capsules

This Class I drug recall was voluntarily initiated by Kvk-tech, Inc. on September 20, 2023 for the product Betaxolol Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0049-2024

Reason for Recall
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Initiated
09-20-2023
Reported
10-25-2023
Quantity
1488 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93101
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and PR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2025
Product Description About Product Description
Full technical description of the product.
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

10702-013-01 Betaxolol Hydrochloride
10702-014-01 Betaxolol Hydrochloride