Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS ...
FDA Recall #D-0136-2026 — Class II — October 14, 2025
Product Description
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
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
103,444 pellets
Distribution
Nationwide in the USA and Antigua
Code Information
Lot, expiry: 3098, 3101, Exp 1/8/2026; 3107, Exp 1/13/2026; 3108, Exp 1/14/2026; 3109, Exp 1/15/2026; 3230, Exp 3/10/2026; 3231, Exp 3/11/2026; 3235, Exp 3/13/2026; 3236, Exp 3/17/2026; 3241, Exp 3/17/2026; 3242, Exp 3/18/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated