Drug 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.
D-0049-2024
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 93101
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1488 bottles
- Official record key
drug-enforcement:D-0049-2024
Official wording
Reason: Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Code information: Lot # 17853A, Exp. 06/30/2027
Distribution pattern: Nationwide in the USA and PR
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets