Drug product
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
D-0128-2026
Product summary
- Event
- Event 97799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,829 pellets
- Official record key
drug-enforcement:D-0128-2026
Official wording
Reason: CGMP Deviations: Potential presence of metal particulate matter
Code information: Lot: 3178, Exp 02/7/2026
Distribution pattern: Nationwide in the USA and Antigua
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Manufacturing or process control
CGMP Deviations