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D-0137-2026Class II

FARMAKEIO OUTSOURCING LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
FARMAKEIO OUTSOURCING LLC
Product type
Drug
Status
Ongoing
Report date
2025-11-05
Distribution
Nationwide in the USA and Antigua
Firm state
TX
Product quantity
264,664 pellets
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Product description

Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01

Code / lot info

Lot, expiry: 3075, Exp 1/2/2026; 3084, Exp 1/6/2026; 3110, Exp 1/15/2026; 3115, Exp 1/16/2026; 3116, Exp 1/20/2026; 3119, Exp 1/21/2026; 3121, Exp 1/22/2026; 3124, Exp 1/23/2026; 3125, Exp 1/28/2026; 3131, Exp 1/29/2026; 3134, Exp 2/3/2026; 3135, Exp 2/4/2026; 3139, Exp 2/6/2026; 3204, Exp 2/13/2026; 3205, Exp 2/18/2026; 3207, Exp 2/19/2026; 3208, Exp 2/24/2026; 3211, Exp 2/25/2026; 3213, Exp 2/26/2026; 3216, Exp 2/27/2026; 3223, Exp 3/4/2026; 3225, Exp 3/5/2026; 3228, Exp 3/6/2026; 3248, Exp 3/19/2026; 3254, Exp 3/25/2026; 3258, Exp 3/31/2026; 3269, Exp 4/1/2026; 3270, Exp 4/10/2026.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →