D-0130-2026 Class II Ongoing
FDA drug recall D-0130-2026 was initiated by FARMAKEIO OUTSOURCING LLC on October 14, 2025 and is designated Class II. Reason for recall: CGMP Deviations: Potential presence of metal particulate matter The recall status is ongoing. Affected quantity: 18,124 pellets.
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2025
- Initiation Date
- October 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,124 pellets
Product Description
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
Reason for Recall
CGMP Deviations: Potential presence of metal particulate matter
Distribution Pattern
Nationwide in the USA and Antigua
Code Information
Lot# 3171, 3172, Exp 2/11/2026