The Recall Desk
HighFDA (Drugs)·D-1239-2022·Announced 2022-07-20

Testosterone Propionate Injectable Vials Recalled Over Sterility Assurance

Testosterone propionate injectable vials are being recalled due to lack of assurance of sterility. The recall affects product 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 an injectable pharmaceutical product where the lack of sterility assurance presents a significant health risk. Per the severity rubric, this qualifies as a risk-of-harm product where no injuries have been reported, resulting in a High severity score.

Plain-English summary

Tailor Made Compounding is recalling testosterone propionate 100mg/ml injectable vials due to a lack of assurance of sterility. The affected product includes 64 vials with the following batch numbers and expiration dates: Batch 12012123A2 (expires 5/30/2022) and Batch 01312212A1 (expires 7/30/2022).

The product was distributed nationwide throughout the United States and Puerto Rico.

Patients who received this product should contact their healthcare provider immediately. Do not use the product. Return unused product to the pharmacy or healthcare facility where it was obtained.

The recalled product

Product
Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable / Hormone Therapy
Hazard
  • sterility-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 (4)

  • Batch#: 12012123A2
  • Exp 5/30/2022
  • 01312212A1
  • Exp 7/30/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category