Drug product
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
D-0123-2026
Product summary
- Event
- Event 97799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,329pellets
- Official record key
drug-enforcement:D-0123-2026
Official wording
Reason: CGMP Deviations: Potential presence of metal particulate matter
Code information: Lot 3294, EXP 4/8/2026
Distribution pattern: Nationwide in the USA and Antigua
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Manufacturing or process control
CGMP Deviations