Testosterone and triamcinolone 12.5 mg pellets recalled over metal particulate

Plain-English summary

Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, one sterile pellet for subcutaneous insertion, compounded by FarmaKeio Outsourcing of Southlake, Texas, is being recalled for CGMP deviations: the potential presence of metal particulate matter.

The recall covers 18,124 pellets from lots 3171 and 3172, expiring 11 February 2026, carrying NDC 73693-0363-01. The product was distributed nationwide in the United States and in Antigua. The FDA has classified the recall as Class II.

The pellet is inserted under the skin, so foreign particulate matter would be introduced into the body. The enforcement record describes the potential contamination and reports no injuries.

Providers and patients holding an affected lot should stop using it and contact the firm or their prescriber.

The recalled product

Product

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

Manufacturer

FARMAKEIO OUTSOURCING LLC

Category

Drug — Hormone implant

Hazard

• particulate-matter
• metal-contamination
• cgmp-deviation
• compounded

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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