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FARMAKEIO OUTSOURCING LLC: Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing,

DrugsSource: FDA (drug) · Date: 2025-11-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
FARMAKEIO OUTSOURCING LLC
Product
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 / hazard
CGMP Deviations: Potential presence of metal particulate matter
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA and Antigua
Recall initiated
2025-10-14
Code info
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.
Product quantity
103,444 pellets
Voluntary mandated
Voluntary: Firm initiated
City
Southlake
State
TX
Country
United States
Event id
97799
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