Testosterone and Anastrozole Sterile Pellets Recalled for Potential Metal Contamination
Asteria Health is recalling Testosterone 100mg/Anastrozole 4mg sterile pellets (NDC 79559-4104-01, Lot 254000104) nationwide due to potential metal particulate matter contamination.
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 product with metal particulate contamination in a sterile injectable formulation poses a direct injury risk, justifying High severity. No illnesses or injuries have been reported and the hazard is characterized as potential rather than confirmed, precluding a Severe rating.
Plain-English summary
F.H. INVESTMENTS, Inc., operating as Asteria Health, is recalling Testosterone 100mg and Anastrozole 4mg sterile pellets due to the potential presence of metal particulate matter in the product.
The affected product is identified by NDC 79559-4104-01, Lot Number 254000104, with expiration date 05/27/2026. The affected lot was distributed nationwide throughout the United States.
Patients who have received this product should contact their healthcare provider for evaluation. Healthcare providers should cease use of the affected lot and follow the manufacturer's instructions regarding return or disposal. No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Injectable Hormone
- Hazard
- foreign-material
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 (2)
- Lot#: 254000104
- Exp. 05/27/2026
Distribution
Distributed nationwide across the United States.
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