D-0049-2024Class I

KVK-Tech, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

KVK-Tech, Inc.

Product type

Drug

Status

Terminated

Report date

2023-10-25

Distribution

Nationwide in the USA and PR

Firm state

Product quantity

1488 bottles

Initiated by

Voluntary: Firm initiated

Reason for recall

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

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.

Code / lot info

Lot # 17853A, Exp. 06/30/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →