KVK-Tech, Inc. is voluntarily recalling a single lot of 10-milligram betaxolol tablets “as a precautionary measure” after a single oxycodone hydrochloride tablet was found on the same production line, according to the U.S. Food and Drug Administration.
Betaxolol is a drug used to combat high blood pressure. Oxycodone hydrochloride is a drug used for pain relief and is a narcotic that’s a “popular drug of abuse,” per the U.S. Drug Enforcement Administration.
The 10-mg betaxolol pills are white, round and film-coated, with one side displaying a “K” and the number “13.” The pills were packaged in white plastic bottles, each filled with 100 tablets, and distributed to wholesalers and retailers nationwide. Bottles in the affected lot — Batch Number: 17853A — have an expiration date of June 2027.
According to the FDA, the company found a single, five-milligram oxycodone hydrochloride tablet on the packaging line during line clearance — the process of making sure equipment is free of materials — after the recalled betaxolol batch was packaged.
“The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration,” the FDA release warns. “Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid.”
“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,” the release reads.
The FDA notes that betaxolol and oxycodone hydrochloride tablets look similar. KVK has not received any reports of foreign tablets in bottles of betaxolol tablets.
According to the FDA release, if you received pills from the recalled lot, stop using them and immediately return them to KVK-Tech. The company will reimburse you for the cost of purchasing the medication, the release states.
You can contact KVK-Tech at 215-579-1842, Ext: 6002, or by email at customerservice@kvktech.com.
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