Compounded Testosterone/Anastrozole Injectable Vials Recalled for Sterility Assurance
Tailor Made Compounding is recalling 106 vials of compounded testosterone/anastrozole injectable due to lack of sterility assurance. The product was distributed 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 FDA recall of an injectable drug with no reported illnesses or injuries documented. The lack of sterility assurance in a compounded injectable represents a significant potential risk to patient safety, as injectable drugs require strict sterility standards to prevent serious infections and complications.
Plain-English summary
Tailor Made Compounding is recalling 106 vials of a compounded injectable containing Testosterone Cypionate 200 mg/mL and Anastrozole 1 mg/mL. The product is supplied in both 4 mL and 10 mL vials.
The recall was issued due to lack of assurance of sterility. The manufacturer cannot confirm that the product was manufactured under conditions ensuring it is free from bacterial and fungal contamination, which is a critical requirement for injectable medications.
The affected product was distributed nationwide in the United States and Puerto Rico. Multiple batch numbers are involved with expiration dates in 2022.
Patients who received this medication should consult their healthcare provider regarding the recalled product and appropriate alternative treatment options.
The recalled product
- Product
- Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- contamination-risk
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 (10)
- Batch#: a)10142123A2
- Exp 4/12/2022
- 02042202A1
- Exp 8/3/2022
- b) 10142121A2
- 10202105A1
- Exp 4/18/2022
- 11102102A1
- Exp 4/30/2022
- Exp 8/3/2022.
Distribution
Distributed nationwide across the United States.
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