KVK-Tech Recalls Hypertension Drug Betaxolol Tablets
KVK-Tech, Inc. is recalling one lot of hypertension drug Betaxolol Tablets, USP 10 mg citing the potential presence of Oxycodone HCl tablet, an opioid pain medication, according to the U.S. Food and Drug Administration.
The recall involves Betaxolol Tablets with Batch Number: 17853A packaged in 50 CC White High-Density Polyethylene or HDPE bottles. The affected Betaxolol Tablets has labeled expiration as June 2027.
The White, Round, film coated biconvex tablets have debossed “K” above bisect, “13” on one side and plain on the other side. The recalled batch was distributed nationwide to wholesalers and retailers.
There are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets.
The recall was initiated as a precautionary measure after finding a single Oxycodone HCl tablet 5 mg, a foreign tablet, on the packaging line during the line clearance after the affected batch was packaged.
However, Newtown, Pennsylvania -based KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg at this time.
The agency noted that betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Some patients prescribed low-dose betaxolol might be have compromised heart and lung function that is also likely to be exacerbated by an opioid.
The FDA said, “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.”
Consumers that may have received Betaxolol Tablets Batch Number: 17853A are urged to stop using the drug and immediately return the product to KVK-Tech for reimbursement.
In similar recalls, Scynexis Inc., which is in exclusive license deal with GSK plc for antifungal drug Brexafemme (ibrexafungerp tablets), last week said it is recalling the drug from the market and placing a temporary hold on clinical studies of ibrexafungerp, citing cross contamination concerns.
In late July, Baltimore, Maryland-based Lupin Pharmaceuticals, Inc. recalled 2 lots of Tydemy oral contraceptive citing out of specification or OOS test results at the 12-month stability time point.
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