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Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERT...

FDA Recall #D-0130-2026 — Class II — October 14, 2025

Recall #D-0130-2026 Date: October 14, 2025 Classification: Class II Status: Ongoing

Product Description

Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01

Reason for Recall

CGMP Deviations: Potential presence of metal particulate matter

Recalling Firm

FARMAKEIO OUTSOURCING LLC — Southlake, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

18,124 pellets

Distribution

Nationwide in the USA and Antigua

Code Information

Lot# 3171, 3172, Exp 2/11/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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