Authored by Jack Phillips via The Epoch Times (emphasis ours),
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.
The release said that customers who purchased the medication will be reimbursed by the company for the cost. It added that if one experiences issues connected to the tables, they should contact a physician or health care provider.
For any questions regarding the recall, KVK can be contacted at 215-579-1842, ext: 6002, Monday through Friday between 8 a.m. and 6 p.m. ET or via email at [email protected].
Other Recalls
Several weeks ago, the FDA announced that Marlex Pharmaceuticals voluntarily recalled one lot of 0.125-milligram Digoxin Tablets USP and one lot of 0.25-milligram Digoxin Tablets USP.
The reason why, according to the notice, is due to a "label mix-up," which could potentially lead to an overdose of the wrong medication. Weaker versions of the heart medication were placed into bottles of the stronger medication and vice versa.
"The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose," the notice said. "Patients who intend to take Digoxin Tablets USP ... would receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose."
"The product is used for the treatment of mild to moderate heart failure," it said. "Digoxin increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date."
Around the same time, a separate FDA notice announced the recall of WEFUN capsules after the agency found the product was tainted with another drug, sildenafil.
"FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall," it said.
Several weeks ago, Glenmark Pharmaceuticals USA and Baxter Healthcare separately recalled drugs that are used to treat hypertension and cancer, respectively. Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets for high blood pressure, while Baxter recalled 13,502 vials of bendamustine HCl injection, used to treat several types of cancer.
Authored by Jack Phillips via The Epoch Times (emphasis ours),
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.
The release said that customers who purchased the medication will be reimbursed by the company for the cost. It added that if one experiences issues connected to the tables, they should contact a physician or health care provider.
For any questions regarding the recall, KVK can be contacted at 215-579-1842, ext: 6002, Monday through Friday between 8 a.m. and 6 p.m. ET or via email at [email protected].
Other Recalls
Several weeks ago, the FDA announced that Marlex Pharmaceuticals voluntarily recalled one lot of 0.125-milligram Digoxin Tablets USP and one lot of 0.25-milligram Digoxin Tablets USP.
The reason why, according to the notice, is due to a “label mix-up,” which could potentially lead to an overdose of the wrong medication. Weaker versions of the heart medication were placed into bottles of the stronger medication and vice versa.
“The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose,” the notice said. “Patients who intend to take Digoxin Tablets USP … would receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose.”
“The product is used for the treatment of mild to moderate heart failure,” it said. “Digoxin increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date.”
Around the same time, a separate FDA notice announced the recall of WEFUN capsules after the agency found the product was tainted with another drug, sildenafil.
“FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall,” it said.
Several weeks ago, Glenmark Pharmaceuticals USA and Baxter Healthcare separately recalled drugs that are used to treat hypertension and cancer, respectively. Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets for high blood pressure, while Baxter recalled 13,502 vials of bendamustine HCl injection, used to treat several types of cancer.
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