KVK-Tech, Inc. in cooperation with the FDA has issued an immediate recall of a single lot of Betaxolol Tablets, USP after another drug was discovered on the line. No incorrect tablets have yet been noted in any dispensed lots of the medication, and no adverse events have yet been reported. However, the combination of the two drugs can be deadly, and all consumers who take Betaxolol should take note.
SUMMARY
Date of Recall:
Announced: September 29, 2023
Public Notification: October 3, 2023
Name(s) of Drug:
Betaxolol
Company Name:
KVK-Tech, Inc.
Drug Indication:
Hypertension (high blood pressure)
Open-Angle Glaucoma
Post Myocardial Infarction (heart attack)
Angina
Product Description
Betaxolol is a prescription-only medication. It is distributed by pharmacies nationwide. Each tablet is round and white with “K” and “13” debossed on one side, and plain on the other. Oxycodone tablets are also round and white, but the information debossed will vary.
Reason for Recall
During a routine inspection, the FDA noted a single Oxycodone HCL, 5mg tablet on the packaging line. Though no Oxycodone tablets were noted inside the packages, the lot is being recalled in case a mix-up did occur.
Impacts
Consumers who regularly take Betaxolol and accidentally ingest Oxycodone may experience an exacerbation of the effects of both medications. Taking Betaxolol and Oxycodone concurrently may cause dangerous slowing of the heart or breathing. This is particularly dangerous for children and those with decreased heart or lung function.
Recall Lot Information
Consumers should locate their medication bottle and compare the numbers listed below to those on the bottle. If they are a match, follow the instructions below to ensure proper participation in recall procedures.
Product Description |
NDC |
Lot Number |
Expiration Date |
Betaxolol Tablets, USP 10mg |
10702-013-01 | 17853A |
06/2027 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
- Continue to monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
- Consumers may contact KVK-Tech Inc. at (215) 579-1842 Ext: 6002. They are available Mon-Fri from 8:00 a.m. to 6:00 p.m. (EST). You can also contact them via email at customerservice@kvktech.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact KVK-Tech Inc. at (215) 579-1842 Ext: 6002 or you can utilize customerservice@kvktech.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact KVK-Tech Inc. at (215) 579-1842 Ext: 6002 or you can utilize customerservice@kvktech.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!