FarmaKeio testosterone/triamcinolone pellets recalled for potential metal contamination
FarmaKeio Outsourcing is recalling testosterone/triamcinolone acetonide injection pellets nationwide due to potential metal particulate matter contamination. Patients should contact their healthcare provider if they have received this medication.
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 drug recall for potential metal particulate contamination in an injectable medication. Metal particulates in a subcutaneous injection pose a potential risk of tissue damage and injection-site injury.
Plain-English summary
FarmaKeio Outsourcing LLC is recalling Testosterone / Triamcinolone Acetonide Pellets (200mg/40mcg) due to current good manufacturing practice (CGMP) deviations that resulted in potential metal particulate matter contamination. The affected product is a sterile pellet for subcutaneous insertion.
The recall affects 264,664 pellets distributed nationwide in the United States and Antigua. Multiple lot numbers are affected, with expiration dates ranging from January through April 2026.
Patients who have received these pellets should contact their healthcare provider immediately to discuss their potential exposure and whether their medication should be removed or replaced. Healthcare providers should quarantine any affected product and return it to FarmaKeio Outsourcing.
The recalled product
- Product
- Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
- Manufacturer
- FARMAKEIO OUTSOURCING LLC
- Hazard
- metal-contamination
- injection-injury
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 (20)
- Lot
- expiry: 3075
- Exp 1/2/2026
- 3084
- Exp 1/6/2026
- 3110
- Exp 1/15/2026
- 3115
- Exp 1/16/2026
- 3116
- Exp 1/20/2026
- 3119
- Exp 1/21/2026
- 3121
- Exp 1/22/2026
- 3124
- Exp 1/23/2026
- 3125
- Exp 1/28/2026
- 3131
Distribution
Distributed nationwide across the United States.
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