Medicine recalls
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| The United States: KVK-Tech, Inc. issues voluntary nationwide recall of one batch of Betaxolol Tablets, USP 10 mg as a precautionary measure due to a single foreign tablet found during the line clearance after the batch was packaged |
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The US Food and Drug Administration (FDA) announces that KVK-Tech, Inc. is voluntarily recalling one batch of Betaxolol Tablets, USP 10 mg (batch number: 17853A) (white, round, film coated biconvex tablets, debossed âKâ above bisect â13â on one side and plain on the other side) to the consumer level. 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.
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.
Please refer to the following website in FDA for details:
http://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
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Oct 4, 2023
Issued at HKT 17:00
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