Drug product
TESTOSTERONE PELLET 100 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: 70168-0101-01
D-0412-2025
Product summary
- Firm
- BSO LLC
- Event
- Event 96792
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,762 vials
- Official record key
drug-enforcement:D-0412-2025
Official wording
Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Code information: Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter