Testosterone/Triamcinolone Pellets Recalled for Potential Metal Contamination
FarmaKeio Outsourcing recalls testosterone/triamcinolone acetonide pellets due to potential metal particulate contamination from manufacturing process failures. The recall affects 36,924 pellets distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of an injectable pharmaceutical product with metal contamination identified during manufacturing. Metal particulates in injectable drugs pose a direct risk of injection site injury. No illnesses or hospitalizations are reported in the source, fitting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling testosterone/triamcinolone acetonide 25MG/5MCG pellets due to potential metal particulate contamination. The affected product is intended for subcutaneous insertion and carries an NDC of 73693-0379-01.
The recall was initiated due to CGMP deviations identified in the manufacturing process. The specific hazard is the potential presence of metal particulate matter in the pellets.
The recall encompasses 36,924 pellets from lot numbers 3148, 3154, and 3155 (expiring 2/5/2026); lot 3162 (expiring 2/11/2026); and lot 3167 (expiring 2/12/2026). Distribution was nationwide in the United States and in Antigua.
Patients and healthcare providers who have this product should be aware of the recall and may contact the FDA or FarmaKeio Outsourcing for additional information and instructions.
The recalled product
- Product
- Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Implantable Pellet
- Hazard
- metal-particulates
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot: 3148
- 3154
- 3155
- Exp 2/5/2026
- 3162
- Exp 2/11/2026
- 3167
- Exp 2/12/2026
Distribution
Distributed nationwide across the United States.
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