Testosterone and anastrozole 4.5 pellets recalled over metal particulate matter
Asteria Health is recalling 100 pellets of Testosterone 100mg, Anastrozole 4mg (4.5) sterile pellets over the potential presence of metal particulate matter.
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: Scored 3 under the risk-of-harm criterion: the record cites potential metal particulate matter in an implanted sterile pellet, with no injuries reported.
Plain-English summary
Testosterone 100mg, Anastrozole 4mg (4.5), 1 sterile pellet, NDC 79559-4104-01, is being recalled by F.H. Investments, Inc., trading as Asteria Health, of Birmingham, Alabama.
The reason given in the enforcement record is the presence of a foreign substance: the potential presence of metal particulate matter.
The record lists 100 pellets, with lot numbers and expiry dates recorded in the enforcement record. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
Metal particulate in a pellet implanted under the skin is a contamination hazard. The enforcement record reports no injuries. Patients should speak to their prescriber, who can confirm whether affected product was used.
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 — Hormone pellet
- Affected units
- 100
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.
Part of a larger recall action
This product is one of 25 recalled by F.H. INVESTMENTS, Inc. (dba Asteria Health) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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