Drug 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
D-0136-2026
Product summary
- Event
- Event 97799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 103,444 pellets
- Official record key
drug-enforcement:D-0136-2026
Official wording
Reason: CGMP Deviations: Potential presence of metal particulate matter
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.
Distribution pattern: Nationwide in the USA and Antigua
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Manufacturing or process control
CGMP Deviations