FDA Recall D-0049-2024
KVK-Tech, Inc. · Newtown, PA
Class I — life-threatening Terminated 678 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Recall record
- Recall number
D-0049-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and PR
- Recall initiated
- 2023-09-20
- Classified by FDA Center
- 2023-10-18
- FDA published
- 2023-10-25
- Terminated
- 2025-07-29
- Recalling firm
- KVK-Tech, Inc.
- Firm location
- Newtown, PA
Drug identification
- Brand name(s)
- BETAXOLOL HYDROCHLORIDE
- Generic name(s)
- BETAXOLOL HYDROCHLORIDE
- Manufacturer(s)
- KVK-TECH, INC.
- NDC(s)
10702-013, 10702-014- Route(s)
- ORAL