Drug 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
D-0132-2026
Product summary
- Event
- Event 97799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43,424 Pellets
- Official record key
drug-enforcement:D-0132-2026
Official wording
Reason: CGMP Deviations: Potential presence of metal particulate matter
Code information: Lot, expiry: 3143, Exp 2/5/2026; 3160, 3161, Exp 2/11/2026; 3165, 3166, Exp 2/12/2026.
Distribution pattern: Nationwide in the USA and Antigua
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Manufacturing or process control
CGMP Deviations