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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE PELLET 200 mg BLUNT, 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: 70168-0121-01

D-0416-2025

April 28, 2025

Class II

Product summary

Firm
BSO LLC
Event
Event 96792
Status
Ongoing
Classification
Class II
Quantity
1,964 vials
Official record key
drug-enforcement:D-0416-2025

Official wording

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

Code information: Lot 20250129@1, exp 1/17/2026; Lot 20250218@4, exp 1/25/2026

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter