Testosterone/Triamcinolone pellets recalled for potential metal contamination
FarmaKeio Outsourcing is recalling Testosterone/Triamcinolone Acetonide pellets due to potential metal particulate matter from manufacturing deviations. The recall affects 18,124 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: FDA Class II recall of an injectable pharmaceutical with potential contamination from manufacturing deviations. This represents a risk of harm to patients, though no illnesses or injuries have been reported.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling Testosterone/Triamcinolone Acetonide pellets (NDC 73693-0363-01) due to deviations in Current Good Manufacturing Practice (CGMP) that created the potential for metal particulate matter to be present in the product.
The recalled product contains 12.5 mg Testosterone and 2.5 mcg Triamcinolone Acetonide per pellet and is intended for subcutaneous insertion. The recall affects Lot Numbers 3171 and 3172, which expire February 11, 2026. A total of 18,124 pellets have been distributed nationwide in the United States and Antigua.
Patients who have received these pellets should contact their healthcare provider. Healthcare providers and patients should not use pellets from the affected lots. No illnesses or injuries have been reported in connection with this recall.
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
- Hazard
- metal-particulate
- manufacturing-defect
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 (3)
- Lot# 3171
- 3172
- Exp 2/11/2026
Distribution
Distributed nationwide across the United States.
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