FDAHealthOctober 14, 2025
FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Sout
⚠️ CGMP Deviations: Potential presence of metal particulate matter
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 14, 2025
Nationwide in the USA and Antigua
What's affected?
- 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
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 103,444 pellets.
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