FDA recall D-0446-2025

KVK Tech, Inc. · Class II · drug

Product

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

Reason for recall

cGMP deviations

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2025-05-09
Report date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0446-2025