Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 1894...
FDA Recall #D-0049-2024 — Class I — September 20, 2023
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.
Recalling Firm
KVK-Tech, Inc. — Newtown, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1488 bottles
Distribution
Nationwide in the USA and PR
Code Information
Lot # 17853A, Exp. 06/30/2027
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated