Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter

Plain-English summary

Testosterone / Triamcinolone Acetonide Pellet, 100MG/20MCG, 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 103,444 pellets across lots including 3098 and 3101 (expiring 8 January 2026), 3107 (expiring 13 January 2026), 3108 (expiring 14 January 2026), 3109 (expiring 15 January 2026) and 3230, carrying NDC 73693-0367-01. 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 Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

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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