Recalls / Class I
Class ID-0049-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
- Brand name
- Betaxolol Hydrochloride
- Generic name
- Betaxolol Hydrochloride
- Active ingredient
- Betaxolol Hydrochloride
- Route
- Oral
- NDCs
- 10702-013, 10702-014
- FDA application
- ANDA078962
- Affected lot / code info
- Lot # 17853A, Exp. 06/30/2027
Why it was recalled
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Recalling firm
- Firm
- KVK-Tech, Inc.
- Manufacturer
- KVK-TECH, INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 1488 bottles
- Distribution pattern
- Nationwide in the USA and PR
Timeline
- Recall initiated
- 2023-09-20
- FDA classified
- 2023-10-18
- Posted by FDA
- 2023-10-25
- Terminated
- 2025-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0049-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.