Compounded Testosterone-Anastrozole Injectable Vials Recalled for Sterility Concerns
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
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 a Class II pharmaceutical recall for lack of assurance of sterility in a compounded injectable product. No illnesses or injuries are reported in the source, and the hazard is a manufacturing quality defect rather than confirmed contamination, placing it in the High category per the rubric.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 39 vials of compounded injectable medication. The recalled product is Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, supplied in 10 mL vials for room temperature storage. Batch #10182113A1 with expiration date April 2022 is affected.
The recall is being issued due to lack of assurance of sterility.
The product was distributed nationwide in the United States and Puerto Rico.
Persons who have received this product should stop use and contact Tailor Made Compounding or their healthcare provider for guidance on next steps.
The recalled product
- Product
- Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 39
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)
- Batch #: 10182113A1
- Exp 4/16/2022.
Distribution
Part of a larger recall action
This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding 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.
See all 52 products in this recall →Related recalls
Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding
See all →- HighHydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighTailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighFDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighEstradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighInjectable Drug Pentosan Polysulfate Sodium Recalled for Sterility Assurance
FDA (Drugs) · 2022-07-20
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22