Testosterone and Triamcinolone Pellets Recalled for Potential Metal Contamination
FarmaKeio Outsourcing LLC is recalling testosterone and triamcinolone acetonide subcutaneous pellets due to potential metal particulate matter from manufacturing deviations. The recall affects 21,324 pellets distributed nationwide and in Antigua.
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 an FDA Class II recall of a sterile injectable drug product due to manufacturing deviations that created the potential for metal particulate contamination. The source reports no illnesses or injuries, and the hazard is potential rather than confirmed, placing this at the High (3) range per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling testosterone/triamcinolone acetonide 87.5 mg/17.5 mcg subcutaneous pellets (NDC 73693-0382-01) due to Current Good Manufacturing Practice (CGMP) deviations. The deviations created the potential for metal particulate matter to be present in the product.
The affected pellets are distributed nationwide in the United States and in Antigua. The recall includes lots 3194 and 3195 (expiration date 2/17/2026) and lots 3196 and 3197 (expiration date 2/18/2026), totaling 21,324 units.
Patients who may have received this product should consult with their healthcare provider about whether they were dispensed an affected lot and what actions, if any, they should take.
The recalled product
- Product
- Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Category
- Drug — Injectable steroid
- Hazard
- metal-contamination
- manufacturing-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 (7)
- Lot
- expiry: 3194
- 3195
- Exp 2/17/2026
- 3196
- 3197
- Exp 2/18/2026.
Distribution
Distributed nationwide across the United States.
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