Concern Over Opioid Tablet Possibly Appearing in Bottle for Antihypertensive Prompts Recall

KVK-Tech is recalling 1 lot of Betaxolol HCl Tablets, USP 10mg after a single Oxycodone HCl 5mg tablet was found on the packaging line.

KVK-Tech is voluntarily recalling 1 lot of Betaxolol HCl Tablets, USP 10mg after a single Oxycodone HCl 5mg tablet was found on the packaging line after the batch was packaged.

Betaxolol is a β1-selective adrenergic receptor blocking agent indicated for the management of hypertension. According to the Company, the affected product (NDC 10702-013-01; Lot 17853A; Expiration date June 2027), which was distributed to retail pharmacies, is being recalled out of an abundance of caution. 

Because the Betaxolol 10mg tablet and the Oxycodone 5mg tablet have a similar appearance, it is unlikely a regular user would be able to distinguish between them. The Betaxolol 10mg tablet has an imprint code of “K” and “13”, while the Oxycodone HCl 5mg tablet has an imprint code of “K” and “18”; both tablets are round and white.

Consumers who may have received the affected product should discontinue use immediately. Inadvertent administration of oxycodone HCl, an opioid agonist, may pose a significant health risk to certain individuals, including those with opioid use disorder, as well as patients with compromised heart and lung function. 

To date, the Company has not received any reports of foreign tablets in any bottle of Betaxolol 10mg Tablets. Adverse events and quality issues should be reported to the FDA’s MedWatch program.

This article originally appeared on MPR

References:

KVK-Tech, Inc. issues voluntary nationwide recall of one lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a precautionary measure due to a single foreign tablet found during the line clearance after the batch was packaged. News release. KVK-Tech, Inc. September 29, 2023. https://www.prnewswire.com/news-releases/kvk-tech-inc-issues-voluntary-nationwide-recall-of-one-lot-of-betaxolol-tablets-usp-10-mg-batch-number-17853a-as-a-precautionary-measure-due-to-a-single-foreign-tablet-found-during-the-line-clearance-after-the-batch-was-pack-301943434.html