D-0129-2026 Class II Ongoing

Recalled by FARMAKEIO OUTSOURCING LLC — Southlake, TX

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
14,329 pellets

Product Description

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

Reason for Recall

CGMP Deviations: Potential presence of metal particulate matter

Distribution Pattern

Nationwide in the USA and Antigua

Code Information

Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.