Betaxolol Hydrochloride tablets recalled due to oxycodone contamination
KVK-Tech's Betaxolol Hydrochloride tablets (10 mg, lot 17853A) are being recalled nationwide due to potential contamination with oxycodone tablets. Patients should stop using affected bottles immediately and contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Although no illnesses or deaths have been reported, the potential presence of a different medication in labeled product containers poses serious health risks. FDA Class I classification mandates a minimum severity score of 4.
Plain-English summary
KVK-Tech, Inc. is recalling Betaxolol Hydrochloride tablets, USP 10 mg (100-count bottles), due to the potential presence of oxycodone HCl tablets mixed into the bottles. The recall affects lot number 17853A with an expiration date of 06/30/2027.
The affected product has been distributed nationwide in the United States and Puerto Rico, comprising 1,488 bottles with NDC# 10702-013-01.
The presence of oxycodone tablets in bottles of Betaxolol Hydrochloride could result in patients receiving an unintended medication, posing serious health risks.
Patients with affected bottles should stop using the medication immediately and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE)
- Brand
- BETAXOLOL HYDROCHLORIDE
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug
- Hazard
- Affected units
- 1,488
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 17853A
- Exp. 06/30/2027
Distribution
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