Status
Terminated
Drug Enforcement D-0049-2024
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Classification
Class I
Report Date
October 25, 2023
Termination Date
July 29, 2025
Product Information
- 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.
- Product quantity
- 1488 bottles
- Reason for recall
- Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and PR
Location & Firm
- Recalling firm
- KVK-Tech, Inc.
- Address
-
110 Terry Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0049-2024
- Event ID
- 93101
- Recall initiation date
- September 20, 2023
- Center classification date
- October 18, 2023
- Code info
- Lot # 17853A, Exp. 06/30/2027
- More code info
- —