D-0049-2024 Class I Terminated
FDA drug recall D-0049-2024 was initiated by KVK-Tech, Inc. on September 20, 2023 and is designated Class I. Reason for recall: Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. The recall status is terminated (terminated July 29, 2025). Affected quantity: 1488 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 25, 2023
- Initiation Date
- September 20, 2023
- Termination Date
- July 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1488 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA and PR
Code Information
Lot # 17853A, Exp. 06/30/2027