Safety Report: KVK-Tech Betaxolol Tablets, USP - recalled due to Potential Presence of Oxycodone HCl tablet, USA

United States

KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time.

Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027.

Risk Statement: The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might be have compromised heart and lung function that is also likely to be exacerbated by an opioid. Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol. Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk.

KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled product. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: KVK-Tech, Inc.
Brand name: KVK Tech
Product recalled: Betaxolol Tablets, USP
Reason of the recall: Potential Presence of Oxycodone HCl tablet
FDA Recall date: October 03, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-one-lot-betaxolol-tablets-usp-10-mg-batch-number