PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: November 5, 2025 Initiated: October 14, 2025 #D-0134-2026

Product Description

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

Reason for Recall

CGMP Deviations: Potential presence of metal particulate matter

Details

Recalling Firm
FARMAKEIO OUTSOURCING LLC
Units Affected
31,124 pellets
Distribution
Nationwide in the USA and Antigua
Location
Southlake, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by FARMAKEIO OUTSOURCING LLC. Units affected: 31,124 pellets.
Why was this product recalled?
CGMP Deviations: Potential presence of metal particulate matter
Which agency issued this recall?
This recall was issued by the FDA Drug on November 5, 2025. Severity: Moderate. Recall number: D-0134-2026.