FDA recall D-0415-2025

BSO LLC · Class II · drug

Product

TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01

Reason for recall

Presence of Particulate Matter: Glass particles were found in pellet vials.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-04-28
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lakewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0415-2025