Recalls / Class II
Class IID-0134-2026
Product
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
- Affected lot / code info
- Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026
Why it was recalled
CGMP Deviations: Potential presence of metal particulate matter
Recalling firm
- Firm
- FARMAKEIO OUTSOURCING LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 920 S Kimball Ave Ste 100, N/A, Southlake, Texas 76092-9019
Distribution
- Quantity
- 31,124 pellets
- Distribution pattern
- Nationwide in the USA and Antigua
Timeline
- Recall initiated
- 2025-10-14
- FDA classified
- 2025-10-29
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0134-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.