Drug product
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
D-0129-2026
Product summary
- Event
- Event 97799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,329 pellets
- Official record key
drug-enforcement:D-0129-2026
Official wording
Reason: CGMP Deviations: Potential presence of metal particulate matter
Code information: Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.
Distribution pattern: Nationwide in the USA and Antigua
Derived failure modes
-
Foreign material or chemical contamination
particulate matter
-
Manufacturing or process control
CGMP Deviations