FDAHealthOctober 14, 2025
FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, So
⚠️ 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 (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
- Lot code
- Lot, expiry: 3143, Exp 2/5/2026; 3160, 3161, Exp 2/11/2026; 3165, 3166, Exp 2/12/2026.
Additional details
Lot, expiry: 3143, Exp 2/5/2026; 3160, 3161, Exp 2/11/2026; 3165, 3166, Exp 2/12/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 43,424 Pellets.
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