FDA recall D-0049-2024

KVK-Tech, Inc. · Class I · 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.

Reason for recall

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

Distribution

Nationwide in the USA and PR

Key facts

Status
Terminated
Initiation date
2023-09-20
Report date
2023-10-25
Termination date
2025-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2024