A drug manufacturer said it is initiating a recall of its blood pressure medication
A drug manufacturer said it is initiating a recall of its blood pressure medication due to the presence of the synthetic opioid oxycodone, according to a notice published by the U.S. Food and Drug Administration (FDA) this week.
KVK-Tech said it is recalling one lot of 10-milligram betaxolol tablets, which were distributed around the United States to retailers and wholesalers, the notice said.
The batch is being recalled as a precaution because a single oxycodone tablet was found on the packaging line during the line clearance when the batch was packaged. The company said it has not received reports of a “foreign tablet” in a bottle of betaxolol.
“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 recall notice said. “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.”
It noted that some patients who are at risk of overdose “are likely to be negatively affected” by receiving oxycodone, a powerful narcotic drug.
That’s even more so if a “substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol,” the recall notice added. “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 betaxolol tablets were packaged in plastic white bottles in counts of 100 tables and have an expiration date of June 2027. The batch number is 17853A.
KVK said it notified distributors and customers by a recall notice letter via email and overnight mail on Sept. 27 and will arrange for the return of the recalled product. A small number of bottles that possibly contain oxycodone might have been distributed to retail pharmacies.
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